Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the manifestation of the company, in compliance with RDC 23/2012, the diversion verified was punctual, there being no risks to the health of the consumer as a visible deviation. If any customer still identifies any units in their inventory, please contact the company to arrange the collection of the product through the e-mail quality@laborimport.com.br
Causa
According to the report of analysis nº 277.00 / 2015, issued by the instituto adolfo lutz, the product disposable hypodermic safety syringe 3ml, safety jet brand, date of manufacture 12/2010, val. 12/2015, lot 101208, was considered unsatisfactory in the aspect assay.
Acción
The Sanitary Vigilance of the Municipality of São Paulo determined the interdiction and collection, by means of publication in the Official Gazette of the City of São Paulo of 04/11/2015, page 53, COVISA Communiqué Nº. 018/2015
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company requests that the product should not be used and that the services that may have units of this lot should contact the company so that it can arrange the collection by means of the email gqt@americamedical.net
Causa
Disappearance in the product aspect test sterile operating field, according to the single sample analysis report 114.198945, issued by lacen ba, for lot 0477.
Acción
The Sanitary Surveillance of the State of Minas Gerais published a Notice of Interdiction of Caution of the Collegiate Management of the Superintendence of Sanitary Surveillance / 09 / DVMC / 2015, on January 23, 2015. The company is performing the product collection.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the company, "at the end of the test, the reader (equipment used in the IVD trials) releases results values that must meet the acceptance criteria indicated in the Instructions for Use. The results are analyzed by qualified persons. is foreseen in the Risk Management Report of the Gold ELISA Chagas kit, considered as a serious risk since failure to meet these criteria invalidates the reaction and makes it impossible to release results. "
Causa
The company received a complaint about the performance of the positive control part of the gold elisa chagas kit, lot cha127a. it carried out investigation and concluded that this reagent presents problems with the stability being able to be outside the required minimum specifications and not to reach the result of expected optical density for the release of the test. in the traceability analysis of the production process, it was identified that the positive control pertaining to the kit cha128a lot has common components with that used in lot cha127a and, as a precaution, included it in the field action. according to the company, the investigation of the occurrence provided subsidies so that they could make sure that the problem is restricted to the positive control.
Acción
Company is performing the recall (for destruction of affected lots) and directing its customers to discontinue use of lots CHA127A and CHA128A. (SEE ANNEXES) - Code: NP 80/15
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Maquet discovered from the complaint records that the PATIENT cassette can be accidentally moved when the CO2 absorber is replaced or when the patient tubes are replaced. If such a cassette is moved while the equipment is running, air leakage may be identified due to a large discrepancy between the inspired and expired tidal volume. The clinical consequence will be the cessation of ventilation. See additional information in the Company's Alert Message, available at http://portal.anvisa.gov.br/wps/wcm/connect/026d2480488daa82a6edeefd7a12d53b/Message+of+Alerta+1582.pdf?MOD=AJPERES. ### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
Causa
Risk of leakage due to accidental displacement of the patient cassette.
Acción
Maquet do Brasil will take corrective action in the field in loco, in the clients that own the products at risk. Product users are advised to always make sure that the appropriate alarm has been selected and to check the tidal volume differences between inspiration and expiration. Excessive force should be avoided when changing patient tubes or CO2 absorber; If this happens, the patient cassette should be pressed back into position, thereby closing the leak - such a procedure can be done quickly, without the need to turn off the equipment.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the company the solution contained in this product presents a potential chemical hazard because the alkaline solution is corrosive and the operator may be exposed when the bottle is leaking. According to the Material Safety Data Sheet, severe burns to the skin and mucous membranes may occur.
Causa
Product or material with loose lids causing leakage during transport. the alkaline solution is corrosive and worker exposure may occur.
Acción
The record holder will collect and destroy the product. The company asks customers to verify that Alkaline Wash, LN 9D31-20, lot 49059UN14 is in use or in stock. If yes, perform, using appropriate personal protective equipment (PPE), visual inspection in your inventory. If any signs of leakage or loose lids are observed, discontinue use immediately and segregate any remaining stock from these kits in accordance with your institution's policy and procedures for later recall. You DO NOT observe any signs of leakage or loose covers, you may continue to use the product following the precautions in the ARCHITECT System Operations Manual and Safety Data Sheet. For more information, see the attached Letter to the Client.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to record holder data, if the Lower Fetal Heart Rate (FHR) alarm threshold setting is not performed correctly, the equipment will only issue the alarm when the FHR value is below 50 BPM (appropriate setting: 120 BPM ). Incorrect configuring at 50 BPM may lead to delays in clinical practitioner responses and adverse events such as fetal bradycardia and oxygen deprivation if the clinical staff does not perceive the FHR value reduction alert. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
Causa
According to information from the registry holder the monitors were delivered with the lower limit of the fetal heart rate (cfc) alarm configured incorrectly at 50bpm, being the standard 120bpm.
Acción
The company will perform a field correction with the sending of an urgent security warning letter, with instructions to the user for the detection of the affected units, and reconfiguration of the lower limit of the Fetal Card Frequency alarm. You should: 1. Review your facility's monitors to determine if any affected products are in use (serial number in the range SAS12048362PA through SAS15114103PAS). * If any monitor is affected, the user must follow the steps below: 2. Check the current values of the lower alarm limit for each affected system. If the limit is set to an appropriate setting, the monitor may continue to be used. Note: The value of the lower limit of the FCF alarm can be verified by any of the following two methods: a. Printing on the tape chart during startup and every 10 minutes when alarms are enabled OR b. The current value of the FCF is shown in the user setup mode (UserSetup) on the monitor screen - see Appendix 1 of the Urgent Security Notice Letter attached to this form for more details. * 3. If the displays are not configured at the required levels or at the default level of 120 BPM, set them to 120 BPM or a level that best meets your needs by following the instructions in Appendix 1 of the Urgent Security Notice Letter attached to this form. Note the serial number of each product checked on the Medical Device Correction Confirmation form (see Appendix 2 of the Safety Notice Letter), and fill in the remaining items on the form. The form must be sent to GE Healthcare within 2 weeks of receipt of this letter. The instructions for submitting the form to GE are contained in it. /////// After the correction, the client should send a correction confirmation form. GE will visit customers who do not submit the correction confirmation form. SEE ATTACHED
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the company, if a health care provider makes a clinical decision based on a Cardiac Index calculated using an incorrect BSA without considering other indicators of cardiac function, the result may be an incorrect diagnosis and / or delayed or incorrect therapy. ///// ** this action will be implemented in conjunction with 2 other FCOs reported: FCO79500336- Epiq 5 (Pediatric Conversion Correction) FCO79500337- Epiq 7 (Pediatric Conversion Correction).
Causa
According to the record holder there is an error in the conversion of the unit weight and height, in the metric setting, in the calculation for the patient's body surface area that results in incorrect calculation.
Acción
The registry holder will perform a field correction of the equipment and advises users to verify that the version of the software used is affected. Philips corrected this problem in versions 1.3.3 and higher. If you have a software version affected, contact your local Philips representative to schedule an upgrade of your software. Note: If Pediatric Cardiology is enabled, please contact your local Philips representative urgently to schedule an update of your software in accordance with FCO79500337. Until your software can be upgraded, the situation can be avoided by ensuring that the Patient Data Units setting is set to "English" units. If this setting is not acceptable to your institution and you need to use the "Metric" units, you can avoid the problem by ensuring the following: 1. After turning on the system, open the Patient Data screen before including an examination. This will put the Patient Data screen back in an appropriate status and the problem will not occur. 2. Ensure that the Patient Data screen is maintained in the Metric units instead of English units. If a height or weight value has to be reported in English [English] units, then it must be converted to Metric manually to avoid the problem. Finally, ensuring that the Patient Data screen is using the Metric units before loading the data of any examination will prevent the data from this examination from being changed.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company reports that OCD internal tests have confirmed cases in which the VITROS® 5,1 FS, 4600 or 5600 Systems allowed the analysis of multiple tests using a single urine sample, regardless of the pretreatment requirements of each selected test, causing potentially outcomes of patients with bias.
Causa
The company that owns the registry informs that urine samples for use with vitros® ca, mg and phos slides require acidification (pre-treatment). the engen ™ system software currently does not route these samples to the manual high priority exit site for pretreatment as indicated. in addition, the engen ™ system software currently allows for the provision of invalid test combinations, which include urine samples with different pre-treatment requirements. depending on the test, urine specimens need to be acidified, alkalized, extracted or untreated prior to being processed on vitros® systems.
Acción
The company directs that the service does not request VITROS® Ca, Mg and PHOS Slide tests using urine samples with no other tests. Do not place urine samples for VITROS® Ca, Mg and PHOS Slide tests on the rail for sorting or routing. Place the pre-treated urine samples for these tests directly into the analyzer. Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company informs that for urine samples from patients who require pre-treatment, place each of the pre-treated sample types in a separate container. Manually program the individual samples. NOTE: A LIS download can be used to program urine samples only if tests that require sample pretreatment and tests that do not require pretreatment are not included in the same sample program. Place this notification on each VITROS® 4600, 5600, and 5.1FS System of your installation or together with the user documentation. Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action.
Causa
The company reported that ortho-clinical diagnostics, inc. (ocd) has confirmed cases for vitros® 5,1 fs (software version 2.8 and previous) and vitros® 4600 and 5600 systems (software version 3.2 and previous). that the vitros® system allowed urine specimens for testing requiring acidification pretreatment to be dosed from the same sample vessel as non-pretreatment tests when samples were programmed.
Acción
The company informs that if this anomaly occurs, it is possible that the VITROS® 4600, 5600 and 5.1 FS Systems process urine samples without correct pretreatment, leading to potential outcomes of patients with bias. See attached table of communication with examples of biased results obtained during the research.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Users must complete and send information requested by the company in a specific form, available in the Urgent Security Notice. The product is not being collected by the company.
Causa
Possible leakage of the device.
Acción
Users should visually examine the device prior to its use and should any damage be identified (tears, tears, signs of bending, etc.) the product should not be used. Review the instructions in the Urgent Security Notice issued by Edwards, available at http://portal.anvisa.gov.br/wps/wcm/connect/d5fb5180488daf34a730effd7a12d53b/ENGLISH+URGENT+POSTURING+POSTURED + M% C3% 89DICO + 1588.pdf? MOD = AJPERES
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The semi-annual maintenance tests indicated that the sample analyzed did not meet the certification criteria, being rejected in the impermeability attribute.
Causa
Suspension of the authorization for use of the product identification identification seal (ocp) due to the failure to perform the semi-annual maintenance tests on the impermeability attribute (check of holes) as evidenced by reports ela / l 260.333 / 3 / 15 (proof) and ela / l 261.498 / 15 (against proof).
Acción
The company is carrying out Field Action for the collection of products manufactured from the date of the last certification
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company informs that Zimmer received a single claim in the world that could possibly be attributed to this dimensional incompatibility of the 4.5mm M / DN bolt. No injury injury or injury to the patient as a result of the incident was reported. The occurrence estimate is 0.00033%. In Brazil, among the 122 units implanted there was no adverse event reported. The company directs health services to report any adverse events.
Causa
Zimmer is starting a recall of the 4.5mm cortical bolts of the m / dn system because it was found during the revision of the historical project files that the entire scope of 4.5mm m / dn cortical bolts could present dimensional incompatibility with the m system / dn. dimensional incompatibility can occur only in the worst case of plant specifications, where multiple dimensional parameters are within the maximum material limits (it means that the stem bore is smaller than possible and the outer diameter of the bolt is as wide as possible). the affected items were distributed from january 2006 to february 2015.
Acción
1. Ensure that affected personnel are aware of the information; 2. Locate all affected products in Annex 1 and remove them from use immediately (segregation / quarantine); 3. The local sales representative Zimmer will make the recall the affected products; 4. Complete the "Acknowledgment of Responsibility Form" and send to - corporatequality.postmarket@zimmer.com and / or sac@wmie.com.br; 5. If after reviewing this notice you have additional doubts please contact your local Zimmer dealer. Adverse effects related to these products in Brazil should be reported directly to the local sales representative, or www.wmie.com.br and through NOTIVISA.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the registry holder, there is a risk of incorrect diagnosis. There is only one affected equipment in Brazil.
Causa
According to the record keeper, cross-reference cross-line lines are displayed in an incorrect position in the fused image, which was generated through post-processing mobiview.
Acción
The company will upgrade the software by reviewing cross-sweep planning only on unmelted stations.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the manufacturer, the probability of reporting an erroneous result (reactive or non-reactive) is unlikely, as this can be detected by quality control. The results of patients obtained with this assay are acceptable if they are followed by valid quality control results.
Causa
Product quality control results out of the expected range. the registry subject relates the issue to the decrease in onboard stability of the ehiv assay reagent.
Acción
The company will perform an update / correction of the instructions for use. Guidance is that if quality control results are not out of the expected ranges, no action is required. If quality control results are obtained outside the expected range, it is recommended that: a. Recalibrate the test every 7 days; B. Replace the reagent cartridge every 14 days. MORE INFORMATION IN THE LETTER TO THE CLIENT ATTACHED
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the record holder, if the yellow tip protector continues to be used with the V5Ms transducer, its life may be shortened. //////// - 09/07/2015 - According to the company the Field Action was completed.
Causa
The yellow tip protector of the transducer, shipped with the v5ms transducer, when not being used for exams, is covered by this protector. the shield is incompatible with the material covering the articulated portion of such a transducer, by coming into physical contact with one another.
Acción
The registry holder will perform a correction of the use instruction and recommends that users immediately stop using the yellow tip protector. After that, perform the leak test for the transesophageal transducer before each use, following the manufacturer's instructions accompanying the tester. Only use cleaning and disinfection solutions approved by the manufacturer. Use transducer sheaths released for the market and designed specifically for transesophageal applications. When storing the transesophageal transducer, take extreme care to keep the distal tip upright. Never move the distal tip by hand. Always use the flexible controls. If you notice any damage or wear on your transducer, or if the transducer does not pass the leak test, immediately stop its use and contact your local Service Engineer.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
This action does not indicate malfunction of the syringe. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the report of completion of the field action proving the sending of the security warning to the client and change of the product registration to include a new alert of the interference with Fulvestrant.
Causa
Nationalization tag error. in the syringe label is labeled model sqk65vs being the correct ssqk / 115vs.
Acción
The company that holds the record will collect the product and advise customers to have the syringes in stock, discontinue use and contact the company.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the manufacturer the health risk is related to the possibility of inappropriate classification, for higher values, of Factor IX, for results of patients in the lower reading range. It is important to know that hemophilia B is characterized by the deficiency of Factor IX coagulation activity that results in prolongation of bleeding after injury, dental extractions or surgeries, and recurrent delay or bleeding before complete wound healing.
Causa
Release of erroneously high results for factor ix with the application protocols of the bcs and bcs xp systems at the lower limit of the measurement range.
Acción
The registry holder will change protocols for the implementation of the Factor IX Define test. In addition, it is advised to discontinue use of the "Factor IX with Pathromtin SL [34]" application protocol and instead use the "Factor IX with Pathromtin SL [463]" application protocol; discontinue the use of extrapolation for reading values at lower levels of the "Factor IX with Pathromtin SL [463]" application protocol and "Factor IX with Actin [467]" application protocol. Do not report patient results below 30% F IX for application protocols "Factor IX with Actin FSL [471]".
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Reactive ribbons based on the enzyme Pyrroloquinone Dehydrogenase Pyrroloquinone Quinone (GDH-PQQ) may lead to false high glucose concentration results in blood samples containing certain sugars other than glucose (maltose, xylose or galactose, for example), given low selectivity for glucose. Mutant variations of GDH-PQQ (mut. Q-GDH) may also undergo galactose interference, which may lead to falsely elevated glucose results in the same way. False high glucose results may lead to an incorrect diagnosis of hyperglycaemia and, sequentially, inappropriate dosing / administration of insulin to the patient, leading to hypoglycemia, coma, or death. False high glucose results can also mask true hypoglycemia. Galactosemia is a metabolic deficiency that causes an increased concentration of galactose in the blood. There is no conclusive study on the frequency of galactosemia in Brazil as a whole; however, a pilot study conducted in the state of São Paulo with 59,953 newborns (10% of all live births in 2006) has identified an incidence of galactosemia of around 1: 20,000 newborns. According to references cited in this study, estimates of the frequency of galactosemia in the world are variable - between 1: 100,000 (Asia) and 1: 14,000 (South Africa). The use of reagent tapes based on GDH-PQQ, or mut Q-GDH, on blood samples from patients with galactosemia may lead to misdiagnosis of high glucose and consequent serious adverse events resulting from inappropriate insulin administration. The risk of serious adverse events may be even greater in the case of neonates with galactosemia, due to the low communication capacity of these patients. In addition, newborns are not routinely tested for galactosemia soon after birth - the test for this alert supplements earlier warning information regarding GDH-PQQ technology, published in 2009: Technovigilance Alert # 992, available at http: //www.anvisa.gov.br/sistec/alerta/RelatorioAlerta.asp?ComeName=CO_SEQ_ALERTA&Parametro;=992. Other important references: See field SOURCE of this alert. [ALERT UPDATED ON 07/09/2015]. [ALERT UPDATED ON 08/17/2015]. [ALERT UPDATED ON 08/26/2015].
Causa
The use of reagent strips based on gdh-pqq or mut. q-gdh may lead to falsely elevated glucose results in blood samples containing excess galactose, which poses a risk for patients with galactosemia (increased galactose in the blood, usually caused by a metabolic deficiency). this situation is more critical for neonates due to the limited communication capacity of these patients, and since the test for the detection of galactosemia is not a standardized test in health facilities.
Acción
Recommendations to users and patients: (1) The use of reagent tapes based on GDH-PQQ technology, or mut. Q-GDH (variation of GDH-PQQ) in blood samples from patients with galactosemia may lead to misinterpretations of high glucose and inappropriate insulin administration; (2) Try to familiarize yourself with the reagent tapes you use, seeking to identify the technology used. Use the instructions for use of the product as a first reference; (3) Do not use reagent tapes based on GDH-PQQ or mut. Q-GDH in patients with galactosemia. These reagent tapes should also not be used in neonates with suspected galactosemia - alternative methods of glycemia should be used in these cases; (4) If in doubt, contact the manufacturer of the product or seek advice from your doctor; (5) Refer to Technovigilance alert # 992 for other risk situations involving reagent tapes based on GDH-PQQ technology and its interference with maltose; (6) When using products based on other blood glucose measurement technologies, make sure these products are indicated for use in newborns (refer to the user / operator's manual) and additionally take into account interferents that affect such technologies. which can also lead to false results of blood glucose concentration; (7). This is a safety alert aimed at highlighting the risk of using the product in a patient-specific clinical condition (galactosemia). The intention is that the information be used to optimize the risk management of the product in health services. That is, the Alert does not define the collection and does not prohibit the use of products based on such technologies, but rather informs specific risk situations that must be evaluated and managed by those who prescribe and use such reagent tapes.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company informs that the hardening of the base paste of the product in question does not pose a risk to the population, since it does not give the product new characteristics that are harmful to health, but prevents its use.
Causa
The product presented a change in the consistency in the base paste of lot 88674f, which consists of hardening of the product, preventing dispensing, making it difficult to use the product.
Acción
The company advises customers who have purchased the product to preventively store it and get in touch with Dentsply for the replacement.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The identified safety problem represents a significant increase in the risk of cardiovascular death in patients with symptomatic chronic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) who are being treated with Adaptive Servoventilation.
Causa
During the preliminary analysis of primary data from the serve-hf clinical study, a serious safety concern was identified. this study investigated the effect of adaptive servo injection (vsa) therapy on hospitalization rates and mortality in patients with symptomatic chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef ≤ 45%) and central apnea moderate to severe predominant sleep (ahi ≥ 15 / h, cahi / ahi ≥ 50% and cai ≥ 10 / h).
Acción
The company advises physicians who accompany patients with symptomatic chronic heart failure with reduced ejection fraction who are using ResMed VSA devices to contact these patients to discuss discontinuation of treatment. Further information in Annexes 3, 4 and 5.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The identified safety problem represents a significant increase in the risk of cardiovascular death in patients with symptomatic chronic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) who are being treated with Adaptive Servoventilation. There were no questions associated with the performance of the VSA therapy device in the study. #### UPDATED ON 07/18/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
Causa
During the preliminary analysis of primary data from the serve-hf clinical study, a serious safety concern was identified. this study investigated the effect of adaptive servo injection (vsa) therapy on hospitalization rates and mortality in patients with symptomatic chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef ≤ 45%) and central apnea moderate to severe predominant sleep (ahi ≥ 15 / h, cahi / ahi ≥ 50% and cai ≥ 10 / h).
Acción
According to the registry holder, up to the completion of the investigation, based on ResMed data, it is strongly recommended that clinicians follow recommendations that warn of the use of ASV therapy in patients with symptomatic chronic heart failure (NYHA 2 -4) and reduced LVEF ≤ 45%, and moderate to severe predominant central sleep apnea. Physicians who prescribe ASV therapy are advised not to place new patients in the at-risk population in the devices and to evaluate current patients. A discussion about continuity or otherwise of ASV therapy should be made if a current patient is considered within the at-risk population. Consequently, as a precaution, physicians should assess individual risks before prescribing therapy with the Philips devices listed above for the population of at-risk patients. No other patient population was identified as at risk for adverse outcomes.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company recommends not to proceed with the implantation of the lens in the patient.
Causa
The company identified an increased incidence of breakage risk in the sofport intraocular lens loop.
Acción
The company BL Industria Otica Ltda., Asks all customers to return the product SOFPORT AO (LL61AO) LENS INTRA-OCULAR ASFERICA. The returned lenses will be replaced. Further information - Attachment - Letter to the Client.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the record holder's information, using height and weight to calculate the BSA, which is a standard practice for patients over 2 years of age, the result may be very high by a factor of approximately 10, that is, the user could immediately identify this error. If a health care provider makes a clinical decision based on a Cardiac Index calculated using an incorrect BSA without considering other indicators of cardiac function, the result may be an incorrect diagnosis and / or delayed or incorrect therapy.
Causa
According to the record holder, there is a unit conversion error in the metric setting for weight and height that can result in incorrect calculation of the body surface area. all of the following events must occur to create a hazardous situation: - system-wide drives are set to "metric" in the setups; - the patient data screen is open, the patient's name, weight and / or height have been entered, the patient data screen is closed; - an image is captured, the examination is terminated; - the system is restarted and the patient directory is opened (but not the patient data screen, or the problem will not occur), - the original examination is included (it does not matter whether through the option "add" or "create". /// when this happens, the system incorrectly converts metric height / weight values to english while still retaining the metric units identification. the displayed height / weight values are incorrect in the report, and the bsa (body surface area) calculation, which depends on height / weight, will be incorrect.
Acción
Philips will do a field correction of the problem by updating the software. You can confirm that your system has been affected by verifying the software version. Philips has corrected this problem in versions 1.0.3 and higher. If you have a software version affected, contact your local representative to schedule your upgrade. ///// Recommendation: Until your software can be updated, the situation can be avoided by ensuring that the "Patient Data Units" setting is set to "English" units. If this setting is not acceptable to your institution and you need to use the "Metric" units, you can avoid the problem by ensuring the following: 1. After turning on the system, open the Patient Data screen before including an examination. This will put the Patient Data screen back in an appropriate status and the problem will not occur. 2. Ensure that the Patient Data screen is maintained in the Metric units instead of English units. If a height or weight value has to be reported in English [English] units, then it must be converted to Metric manually to avoid the problem. Finally, ensure that the Patient Data screen is using the Metric units before loading any survey data. This will prevent your data from being altered.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The record holder has reported that all products specified in this field action are in stock.
Causa
Manufacturer integra lifesciences has identified batches of improperly assembled intracranial pressure monitoring cata- tes. the ring of the screw adapter may be in the wrong place and there is a potential risk of blood leakage from the adapter.
Acción
The company that holds the registration will collect the product for return to the manufacturer. We ask users of this type of product to verify that they own the model products and the affected series. If you have the specified product, discontinue use and contact the holder.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the company, if the Gantry Motion Control Board (MCB) fails, limiting the movement of the fluoroscope may interfere, complicate or prolong any interventional procedure that is dependent on multiple fields of view , affecting the diagnostic and therapeutic accuracy of the image. The ability to perform imaging and diagnostics can also be impaired.
Causa
Safety problem related to the loss of the ability to move the arm gantry in c (c-arm) in the system of interventional imaging of fluoroscopy. loss of gantry movement capacity is caused by a failure in the gantry motion control board (mcb). after system reboot, x-rays and manual movements of the gantry and table shafts will be available.
Acción
The company will make a field correction of the affected equipment. The user can continue to use the system, avoiding abrupt changes of direction with the movements of the gantry and preventing potential collisions with other equipment. If failure occurs during an interventional examination / procedure, the user should ensure that he / she has the procedures in place to handle patients in the event of loss of gantry movement as described on the labeling of their product.