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 will add a phrase in the instructions for use of the disconnection systems, warning that the product should not be used in patients with a known history of allergic reactions to iodine. Check full information in the alert message published by the company, available at: http://portal.anvisa.gov.br/wps/wcm/connect/99fa2e00472fc243aafebbbb1e455ac3/Carta+ao+Cliente.pdf?MOD=AJPERES
Causa
Warning about the need to observe the situation of iodine allergy in the patient undergoing peritoneal dialysis, using any of the products mentioned in this alert.
Acción
The products in question should not be used during therapy (peritoneal dialysis) in patients with a history of iodine allergy. The company is sending customers a safety alert with an update of the instructions for use.
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
Company recommendations to users and patients: "Through the publication of the Resolution, we recommend to users and patients that there is some type of adverse event involving the products mentioned in the Collection Action (which can be verified on the Traceability Labels sent to each product) , must be reported to the Distributor and Meta Bio. "
Causa
Possibility of existence of products already marketed that may present some variation regarding sphericity requirements, according to normative requirement (nbr iso 7206-2 and nbr iso 21534).
Acción
The company is doing the Recall of the batches manufactured before 7/23/2014. (List in ANNEX). Company is communicating its distribution chain so that it divulges to its clients (health services) (Letter in ANNEX).
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
In this way, Politec Importação e Comércio Ltda., Will arrange the voluntary collection of this product, fulfilling us contact V. Sa. in order to inform about this recall and the temporary suspension of product supply. The subject of this recall includes different lot numbers as indicated in the table below, noting that batches received by V. Sa. are the ones mentioned in the body of the email. In view of this recall and given the procedures stipulated by regulatory agencies, among other provisions also applied, we require that you. take the following measures: 1) Cease the use and distribution of batches of listed products 2) Complete the attached acknowledgment report, sign it and send it immediately to recallsage@politecsaude.com.br. This will allow confirmation of receipt of this notification and also confirmation of the quantity of this product in your hands. 3) If you have in stock for resale, consumption or any other purpose any batches of the product subject to such recall segregate it. The form of compensation through credit or exchange will be informed in a timely manner. 4) As a distributor or reseller of our products, we require you to inform us who has or has shipped the product on screen. Please use the enclosed worksheet. Politec Importacao e Comércio Ltda., Is taking all applicable measures to avoid any inconvenience that may arise from this recall voluntarily initiated by Sage Products Inc .. For any information or clarification on this subject, Milena Raizer (recallsage@politecsaude.com.br) or by phone 11 - 99690-4626.
Causa
Potential contamination of certain batches of the product by the bacterium burkholderia cepacia./// according to sage products inc., topical administration of the possibly contaminated product may, under certain circumstances, cause infections in immunocompromised users and hospitalized patients, as well as in groups of patients.
Acción
Field Action No. 141/16 triggered under the responsibility of the company Politec Importação e Comércio LTDA. Classification of risk: II Classification of the field action: Recollection; Return to the manufacturer. Politec Importação e Comércio Ltda., Will arrange the voluntary collection of this product, fulfilling us contact V. Sa. in order to inform about this recall and the temporary suspension of product supply. The subject of this recall includes different lot numbers as indicated in the table below, noting that batches received by V. Sa. are the ones mentioned in the body of the email. In view of this recall and given the procedures stipulated by regulatory agencies, among other provisions also applied, we require that you. take the following measures: 1) Cease the use and distribution of batches of listed products 2) Complete the attached acknowledgment report, sign it and send it immediately to recallsage@politecsaude.com.br. This will allow confirmation of receipt of this notification and also confirmation of the quantity of this product in your hands. 3) If you have in stock for resale, consumption or any other purpose any batches of the product subject to such recall segregate it. The form of compensation through credit or exchange will be informed in a timely manner. 4) As a distributor or reseller of our products, we require you to inform us who has or has shipped the product on screen. Please use the enclosed worksheet. Politec Importacao e Comércio Ltda., Is taking all applicable measures to avoid any inconvenience that may arise from this recall voluntarily initiated by Sage Products Inc .. For any information or clarification on this subject, Milena Raizer (recallsage@politecsaude.com.br) or by phone 11 - 99690-4626.
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
Company recommendations to users and patients: "Through the publication of the Resolution, we recommend to users and patients that there is some type of adverse event involving the products mentioned in the Collection Action (which can be verified in the Traceability Labels sent to each product) , must be reported to the Distributor and Meta Bio. "
Causa
Possibility of existence of products already marketed that may present some variation regarding sphericity requirements, according to normative requirement (nbr iso 7206-2 and nbr iso 21534).
Acción
The company is doing the Recall of the batches manufactured before 7/23/2014. (List in ANNEX). Company is communicating its distribution chain so that it divulges to its clients (health services) (Letter in ANNEX).
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
Company recommendations to users and patients: "Through the publication of the Resolution, we recommend to users and patients that there is some type of adverse event involving the products mentioned in the Collection Action (which can be verified on the Traceability Labels sent to each product) , must be reported to the Distributor and Meta Bio. "
Causa
Possibility of existence of products already marketed that may present some variation regarding sphericity requirements, according to normative requirement (nbr iso 7206-2 and nbr iso 21534).
Acción
The company is doing the Recall of the batches manufactured before 7/23/2014. (List in ANNEX). Company is communicating its distribution chain so that it divulges to its clients (health services) (Letter in ANNEX).
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
As described in the Instructions for Use of the Colleague Pump, they are able to infuse medications, solutions, parenteral nutrition, lipids, blood and blood components. It is important to note that, according to the manufacturer, the Colleague Infusion Pump is NOT designed for enteral administration (SEE CUSTOMER LETTER). /// According to the manufacturer's information there is no risk to patients of injuries. A failure in the amount of solution administered may occur due to flow failure during administration. In this case the patient may present with adverse symptoms such as abdominal distension, diarrhea and hyperperistalse.
Causa
Identified by the company the incomplete validation of the equipment according to the requirement contained in the specifications of the colleague infusion pump. in this case, flow rate and volume may fail during enteral use. in use, it is also possible to have faults in closing the flow control valve of the colleague pump (code 808: 03).
Acción
The company issues a safety alert to customers stating that when using the Colleague Infusion Pump teams, appropriate medical follow-up should be requested. Customers listed on the distribution map (SEE ANNEX), must fill out the Customer Response Form (SEE CLIENT LETTER) and send the company. In case of being a distributor, the orientation is to pass the Letter of clarification to your customers who have purchased the material.
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, there were no reports of injuries due to this failure mode, but when the vertical brake malfunctions, the technician, patient or other users who are near the table may suffer an injury.
Causa
According to the registry holder there is a possible vertical brake failure, which may lead to uncontrolled movement of the patient's bed. there are no reports of users being injured.
Acción
The record holder's recommendations, in the event of an uncontrolled vertical movement of the patient's bed, the use of the equipment should be discontinued and the user should contact the local care provider. The company does not guide stopping in the use of the bed. Users who prepare and operate the system with the patient should be aware while the patient is on or near the Patient Bed, especially in the case of intubated patients or in similar situations. These guidelines must be followed until the equipment is corrected.
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 there is no risk to the patient using lots of the affected products before their collection.
Causa
Urine collector leakage for urinary incontinence due to the presence of holes in the penile collector.
Acción
The company will collect the product and include it later in the monitoring form.
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 manufacturer's information, using the Colleague infusion pump with old wiring may result in an inaccurate time remaining battery level or the option to operate with battery power may become unavailable. In the event of a failure or event with the battery (which is extremely unlikely to occur), this situation could contribute to a delay in infusion or interruption of the infusion.
Causa
According to the information disclosed by the company, 18 serial numbers of the colleague pump were identified that had the "yuasa" battery replaced during service, but battery wiring was not changed as required in the specification.
Acción
The company will correct the devices in the field and send Letter to the Client (SEE ANNEX) to those who have the equipment affected. Segregation of affected equipment is requested and completion of the Customer Response Form (APPENDIX). Once completed, send it to fax number 0 (XX) 11 5653-0106 or email faleconosco@baxter.com. LIST OF EQUIPMENT DISTRIBUTION IN ANNEX.
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, a problem with the equipment's power adapter may result in increased potential for electric shock to the user.
Causa
Siemens healthcare diagnostics reported damage to the external power adapters that come with clinitek status®, clinitek status® +, and clinitek connect status® connected to the urine analyzers.
Acción
Siemens advises its customers to turn off the device and disconnect the power adapter from the power outlet to check the Code Identification Register raised. • If your power adapter has one of the aforementioned raised ID codes, immediately stop use and discard the power adapter. • If your power adapter does not have one of the ID codes listed above but is cracked or damaged in some way, immediately stop use and discard the adapter.
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 Meta Bio Industrial Ltda - CNPJ 02513989 / 0001-62, NOTIFIED to complete and send the Field Action Notification Form, and subsequently, the other forms as provided in IN 001/2012 of RDC 23/2012. GEMOR - Management of Risk Monitoring, will be monitoring the stock collection actions in the market.
Causa
Possibility of the existence of products already marketed that may present some variation as to sphericity requirements,.
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
As a result of an evaluation carried out by the company on complaints received between 2011 and 2013 involving the product, it was observed that a significant number of notifications reported that the equipment did not care; after evaluation of the data, the root cause was attributed to an error of use due to non-release of the manual tube from the equipment tube. The Colleague Infusion Pump Operator's Manual tells you which procedure to follow when Manual Tube Release (LMT) is used. Check for additional information in the Baxter Alert Message, available at: LINK - AWAITING PUBLICATION.
Causa
The equipment may not turn on because the equipment is set to manual tube release (lmt) mode, potentially delaying therapy delivery.
Acción
Baxter Hospitalar Ltda is sending a safety notice to customers who own the product in question, alerting them to the problem and requesting the instructions contained in the product manual.
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
Company recommends: "* If the lipid panel (Triglycerides, Triglycerides, Triglycerides Concentrate, Cholesterol Concentrate and LDL Direct Cholesterol) is not being used together with the determination of Lipase in ADVIA Chemistry Systems, no action is required. * If the lipid panel is used in conjunction with Lipase in the ADVIA Chemistry Systems, Siemens recommends the following protocol to minimize the potential for falsely elevated Lipase assay results. a) Customers with two or more ADVIA Chemistry Systems shall perform the defined tests on the Lipid and Lipase panel in ADVIA Chemistry Systems separately. b) Clients with a single ADVIA Chemistry System and laboratories that choose to maintain lipase in the same system with the lipid panel should perform the automatic replication protocol described in the Letter to Customer to mitigate the possibility of obtaining falsely elevated Lipase test results. ".
Causa
Siemens healthcare diagnostics has identified a high bias potential for the lipase assay in advia chemistry systems due to carryover of one or more of the following tests: triglycerides, triglycerides 2, triglycerides concentrate, cholesterol concentrate and ldl cholesterol direct. the potential carryover by these reagents can be mitigated from the design of designated contamination avoidance protocols. however, under certain circumstances, rare carryover incidents may occur.
Acción
The company is contacting its clients and providing guidance on the procedures to be followed (ANNEX) CHC Code 15-07
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, the risk is linked there is a possibility of collision of the equipment with the patient or with the staff present in the room. When suspended from the ceiling of the monitors, it may fall to its lowest position. There is also the possibility that the ceiling suspension of the monitors collide with other equipment that is close to it.
Causa
According to the record holder, the ceiling suspending system of the equipment monitors may plummet to its lowest position which, after investigation pointed out that the cause of the failure was a montage suspended ceiling trigger assembly error.
Acción
The registrant has established the following guidelines for customers until the containment action is implemented: - Do not position or move the ceiling suspension of the monitors on the patient - Do not allow team members to be under or near the suspension monitors.- Avoid any unnecessary movement of the monitors suspended ceiling. " (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
The holder of the registration informs: "The possibility of a rupture in the quench tube, which may cause the helium gas to leak into the magnetic room or any other area near the quench tube. In rare cases, this helium gas may lead to a displacement of oxygen in the air causing danger by asphyxiation in people in the area. Other hazards, such as freezing, can be caused by the extremely low temperatures of helium gas. #### UPDATED ON 08/21/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
Causa
Siemens has detected that in some cases siemens magnetom systems with superconducting magnets may have been installed by omitting essential safety requirements for the installation of the quench tube.
Acción
The registration company advises users to wait for the quench tube check by the Siemens team. If, during the inspection, you detect any discrepancies with the requirements of Siemens, the user will be informed separately about the type of divergence together with a plan of how it will be corrected. (SEE ANNEX CUSTOMER LETTER)
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
At the moment, no technical complaint regarding this model / batch has been registered that could offer any risk to its users. This was a field action triggered based on the information received from COVISA (SP), published in the DOC of 11/27/2014 - page 81. #### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action proving the destination of non-compliant products.
Causa
Identified the presence of a foreign body (hair) attached to the sealing of the packaging of this needle, resulting from unsatisfactory aspect analysis.
Acción
The company that holds the register will collect the needles. The company advises customers to immediately discontinue the use of the product from the batch mentioned, segregating them and identifying them so that they are not inadvertently used. They will be collected and destroyed. (LETTER TO THE CUSTOMER IN ANNEX)
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 manufacturer's information, if the connector tube is cracked and leaking, and the user does not replace the fluid bottles in the yellow warning system and the tank is empty, the system will signal results with an error signal since the fault of acid / base solution is detected. In this case, a limited number of test results processed before the error signal (up to 20 tests) can be affected and not flagged; however, several subsequent signal errors would indicate that a system malfunction has occurred and that the results need to be verified. #### UPDATED ON 08/21/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
Causa
As described by the record holder, a problem was found in the fluid reservoir connector tube of the advia centaur and advia centaur xp immunoassay systems. a small break in the plug tube in the reservoir connector may occur due to mechanical stress. breakage may result in minimal dripping over the reservoir or the tray located below the reservoirs. there is a potential for leakage of a minimal amount of fluids out of the system.
Acción
The registration keeper advises customers: 1. Immediately replace the vial for all fluids when the yellow alert appears. This will reduce the possibility of improper dispensing of fluids. 2. Refer to the ADVIA Centaur or ADVIA Centaur XP Operator's Manual for the bottle replacement procedure. 3. Use Personal Protective Equipment (PPE) when in contact with any liquid leaking from the system. 4. Examine the system for any fluid in the flask of the vials. If fluid is present, contact the Siemens Customer Care Center (0800-129-633) or your local Siemens technical support representative to schedule a visit. In addition, Siemens recommends retaining the letter with the laboratory records and forwarding the notification to anyone who may have access to the products.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Abbott Laboratories safety note regarding the ICT Calibrator Serum Calibrator in the Potassium test
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 data from the manufacturer the health risk related to this issue is limited to the delay in the detection of hyperbilirubenia, while the result is confirmed by biochemical tests if the value found is lower than expected. If you get a result that is greater than expected, phototherapy would already be started and any change in therapy would require confirmation by laboratory biochemical tests.
Causa
Siemens healthcare diagnostics reported a change in the measurement of the neonatal bilirubin parameter (nbili), which may have a variable increase when the concentration of nbili is> 12mg / dl (205 μmol / l) and the thb concentration exceeds the reportable range greater than 25 g / dl (15.5 mmol / l). when this occurs, the analyzer may report results of nbili greater or less than expected.
Acción
Siemens advises customers to perform the procedures described below, and to wait for the company to be scheduled for correction and to file the letter with the laboratory files: • If your analyzer reports "----- ↑" in the result of tHb, and the nBili result is reported, do not release the nBili result reported by the analyzer. • Please review the letter with the Clinical Director of your Laboratory. • Fill in and return the Effective Verification Form attached to the letter to the customer within 7 days. /// (SEE LETTER TO THE CUSTOMER IN ANNEX)
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, failure of the caster assembly equipment may result in fan drop / tilt (imbalance).
Causa
The company informs that specific combinations of engstrom fan casters and bases have been identified that are more likely to fail the caster mounting equipment. failure of the caster mounting equipment may result in fan dropping / tilting (imbalance). a fall / tilt of the engstrom fan may result in serious injury to patients or clinic staff.
Acción
GE Healthcare of Brazil makes it clear that customers can continue to use the Engstrom fan equipment. If the fan equipment is mounted on a cart, make sure that the carriage assembly is fully tightened and shows no signs of damage. If there are signs of damage, contact the GE Healthcare service or your local service representative. GE Healthcare will fix all affected systems at no cost to the customer. A GE Healthcare Technical Services representative will contact you to perform this fix. (SEE CUSTOMER LETTER)
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 importing company clarified that the product will be collected and forwarded to the manufacturer. There was no report of patient harm or adverse health effects associated with this complaint. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
Causa
The company integra lifesciences has identified that there is a possibility that the pbto² readings may be underestimated due to an improperly programmed smart card when using one of the catheters.
Acción
The company holding the record explained that of the affected products, it had imported only one lot, all were still in the company's stock and, so far, we had not marketed any units. Fifteen units were imported and they were segregated and later returned to the manufacturer.
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, the problem occurred in an equipment unit. The unit was not in use so no injuries were reported as a result of this problem. The cause of cable breakage after the investigation was performed was fatigue. Rupture of the structure may cause bucky to fall during use of the equipment and possible injury to a patient or operator.
Causa
According to information from the record holder, both the steel wire ropes of the proteus x-ray system's wall bracket rupture, causing the bucky cabinet to fall to the floor.
Acción
According to company information, if you observe any abnormal movement of the wall mount bucky of the Proteus XR / a x-ray imaging system, you should immediately stop using it and contact your local GE Healthcare service representative . (See Customer Letter) The user should also check that the service procedure is up to date. The procedure is available at the link below: http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library The search instructions are detailed in the consumer letter (page 2).
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 is an electronic defect in the intermittent alarm of the product, which in certain circumstances may lead to a situation in which the five-minute sound signal from the fluoroscopy does not sound. Through customer complaints and internal testing, Philips Healthcare has discovered an intermittent electronic defect in the product. According to the company, the problem does not create a dangerous situation, however the beep is an available tool to help avoid the excessive incidence of radiation in the patient. See Security Notice published by the company, available at: http://portal.anvisa.gov.br/wps/wcm/connect/f4260380478c61258259ebfe096a5d32/Aviso+de+Seguran%C3%A7a+-+FCO72200270.pdf?MOD=AJPERES
Causa
Five minute product alarm does not sound intermittently.
Acción
Philips will perform a software update to fix the alarm problem (installation of the new version R7.2.8). Until software correction is performed, the user must observe the real-time dosing information and accumulated fluoroscopy time reported by the system - the failure condition is restored when a new patient case is initiated, or when the system is restarted.
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
Suppliers and health care facilities using this product should alert product users to incorrect product information on the product label, thus avoiding the possible (incorrect) use of spheres with diameters of less than 500 micrometers in the case of uterine fibrosis. The information in the Instructions for Use is correct as to the indication of use of the product.
Causa
Incorrect product labeling in english stating that product sizes 100-300μm and 300-500μm can be used for uterine fibrosis (when in fact only products of size 500-700μm, 700-900μm and 900- 1200 μm are indicated for uterine fibrosis).
Acción
The company has already started communicating the problem to its suppliers and customers. Users of the product should pay attention to the information contained in the Product Use Instructions, which are correct. See the alert message at: http://portal.anvisa.gov.br/wps/wcm/connect/c5073c0047951ed683cbebfe096a5d32/Community+Access+of+Camp .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
According to the manifestation of the company, the various indications for the use of Stratos implants result in very different mechanical load characteristics. There are also factors that exert an unpredictable influence, conditioned by the patient's lifestyle after the surgery, by observing the physician's indications and by the patient's collaboration. Implants only fulfill their mission until the healing and healing of bones is complete. After that, they no longer have mechanical function, being considered foreign bodies for the locomotor system. Especially in retrosternal implantation (pectus excavatum), the risk of rupture of isolated implants presents an increased risk for the patient. It also indicates that the risk assessment is essential for the doctor. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
Causa
The manufacturer of the product evaluated the possibility of rupture of the transverse rods / connectors of the stratos system in patients operated for more than 18 months to correct pectus escavatum with the ravich technique. the company received adverse event notification (implant break) in a patient operated for more than two years. as a result of the research process the product failure was attributed to the implant capacity overload.
Acción
The company that registers in Brazil advises that implants should be removed approximately 12 to 18 months postoperatively. In all cases, postoperative monitoring of the patient is mandatory. It is recommended that patients be examined at appropriate intervals (all 4 to 6 months). In all post-operative examinations, chest x-rays should be taken at two levels to check if the reconstruction is intact. The decision on the removal of the implant and the time of execution should be evaluated on a case-by-case basis, according to the extent, location and possible discomfort of the patient.