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 instructions for use the results should only be reported if the values are within the range defined as acceptable. That is, incorrect results should not be reported to patients. The associated risk is due to delays in the screening of patients for pre-eclampsia and Down's syndrome in the first trimester.
Causa
Problem related to the stability of lot 637341 of pigf calibrators of the delphia pigf kits (6007-0010, 6007-000 and 6007-002c). the problem is limited to a batch of the pigf calibrators, which is included in the described pigf kit lots. due to the stability problem, there is a tendency to decrease the signal level measured in the calibrators to 20%.
Acción
The company that holds the registration guides the immediate discontinuation in the use of the DELFIA Xpress PIGF kit lots highlighted in this field action. The kits should be destroyed. It is requested the analysis of the PIGF control values for the enumerated lots, complete verification. In case QC controls are within acceptable range, the results of samples should be considered valid. If there are deviations, it is recommended to repeat the samples with another kit lot. The kits will be replaced by 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
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
Causa
Resmed has issued an urgent safety notice describing an absolute greater annual risk of a statistically significant 2.5 percent cardiovascular mortality rate for individuals randomized to resmed assisted ventilation (asv) therapy compared to the control group. in the population of patients with reduced left ventricular ejection fraction (lvef ≤ 45%), 10% of the asv group suffered vascular death per year compared to 7.5% of the control group, representing a higher risk of cardiovascular mortality (hr = 1.335, 95% ci - (1.070, 1.666), p value = 0.010).
Acción
The registry holder recommends not placing new patients with symptomatic CHF (NYHA 2-4) and LVEF ≤45% and predominantly moderate to severe central sleep apnea in ASV therapy. Before using therapy, each patient should be evaluated for Heart Failure. In the case of signs and symptoms for this disease, an objective evaluation of LVEF should be performed. Current patients should also be evaluated and a discussion of whether or not therapy should be continued should be considered within the at-risk population.
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
Check your stock and segregate the products at risk as soon as possible, avoiding their use. Send Stryker the CUSTOMER RESPONSE form provided by the company.
Causa
There is a potential risk of the probes related to the above mentioned batches rupturing and releasing fragments into the joint space, and an eventual need for immediate surgical intervention to remove the fragments may arise. in addition, there is a potential risk of the fragments remaining within the joint space, which may result in a compromise of function.
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, Quality Control has failed because a strain expected to be susceptible to the antibiotic appears to be resistant. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and destination of the nonconforming products.
Causa
Internal failure in quality control. identified a deviation of performance associated with the quality control test from retained product samples, resulting in results outside the specification of resistant strains.
Acción
The company will not send the letter to the customer once the unit of the batch marketed, at the time of the investigation, had its expiration date. If the customer has performed quality control tests and presented result accordingly, the strips can be considered safe.
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 registry holder reported that the risk of an incorrect diagnosis associated with the problem is low.
Causa
The registrant has identified that by repositioning the virtual touch iq region of interest from its original (default) location, the lateral position of the measuring tool may not be in line with the lateral position of the shear rate data.
Acción
The company that holds the registry will continue to use its equipment as long as it does not reposition the region of interest of the Virtual Touch IQ from the original location (default). This problem will be corrected with new software.
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 potential risk pointed out by the company is an incorrect diagnosis.
Causa
The doppler manual plotting tool in a full-screen format presented a possible miscalculation. the tool can incorrectly calculate the medical time rate (tav) and, consequently, incorrectly calculate the pulsatility index (pi).
Acción
The company directs you not to perform measurements using the Doppler trace tool in a full-screen display format. The fix of the problem will be in a software released later (update). It is necessary to share the attached Letter with the users of 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
In addition to touch-key failure, enabling an e-stop or a system power failure between 0.05 and 0.1 seconds after the start of the movement, may cause this fault to occur. Even so, the record holder recommends reliably emergency stop.
Causa
According to the record holder there is an account of unintentional movement of the sensor. the main cause of this movement was determined as a simultaneous failure of two components, the radial brake circuit and the touch keypad. this combination of failures resulted in shaft brake inefficiency, which gave rise to sensor movement.
Acción
The registration company directs customers to continue to use the equipment. It is recommended to observe the patient during the examination. The company has developed and will install an improved brake control circuit to correct this condition. You should ensure that this safety information is included in the instructions for use of the system. As usual, Siemens recommends observing the patient during the exams. If difficulties occur or a fault occurs while performing the daily touch-tone test, it is recommended to discontinue use and contact Siemens Technical Support. If unintended movement of the sensor is observed, remove the patient, interrupt the use of the system and contact Technical Assistance.
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
Considering the problem related to the locking of the system in the "Fluoro Bypass" mode, it is possible that there is no radiation release and no fluoroscopic images are acquired. The risk would be more related to the delay due to the system restart. In the second problem presented the risk are related to the possible unexpected movement of the equipment resulting in collision.
Causa
Two problems with the system have been described by the company that holds the registry: the first would be in case of an error in the equipment and it is in the "bypass fluoro" mode, while the x-ray blocking function is active, it will not be the only way out of this function is to solve the root cause of the equipment being in the "bypass fluoro" mode or to restart the system. the other problem is related to the possible failure of the position sensor on the articulated base axis that is not detected by the system software. following activation of operator movement, the c-arm system may move unexpectedly faster than normal.
Acción
The company intends to continue to use the equipment until the company engineer's visit is made for field correction of the equipment. The field correction corresponds to the software update by installing two packages (11 and 12).
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 informs that the problem involves a failure of the equipment having no influence on the treatment of patients.
Causa
In case the table is near its maximum extension at the end of the head and there is a large amount of liquid on the table surface, the liquid may infiltrate the table through the existing fault and cause contamination of the electronic components. in the event of contamination, table movements may not occur.
Acción
The holding company will do the sealing in the failure of the top cover of the table column. This will ensure protection against ingress of liquids. The company will contact customers to schedule a visit to carry out corrective 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 clarifies how the QC results may be low average values, but still within 2 standard deviations (SD), there is a potential risk of erroneously generating low PO2 results in patient samples, especially in blood samples, in values below 50 mmHg of PO2. The company further reports that to date, there are no known cases where this issue caused any serious adverse events for patients.
Causa
Roche diagnostics gmbh, a legal manufacturer of the products involved in this notification, after complaints and internal investigations, has identified changes in qc (values of cq below target values) of the po2 parameter in the cobas b 123 poc systems caused by a calibration problem with the parameter po2 in specific batches of cobas b 123 fluid pack (200 and 400 tests) and cobas b 123 fluid pack coox (200, 400 and 700 tests).
Acción
Actions to be taken by the customer / user The company recommends that: - For the affected batches of cobas b 123 Fluid Pack listed in Table 1 currently in use, the PO2 parameter must be deactivated in the equipment. Requests that the detailed workaround presented in Appendix 1 to the Customer Letter (Annex 2) be followed. - Cobas b 123 Fluid Packs from affected batches not yet in use can be disposed of on site. - Replacement of affected lots may be requested from Roche Diagnóstica Brasil Ltda. The company notes that not all drives have this error, but for security reasons, requests that they not use the affected batches listed with the PO2 parameter enabled. Distribution map - Annex 3
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 that the user be aware of the following guidelines: "As often required, always ensure that the correct DRRs of the current patient are displayed in ExacTrac and that a precise fusion with the X-ray images for patient placement is possible. If incorrect DRRs are displayed, quit and restart the ExacTrac software. To minimize the likelihood of this problem occurring in the affected ExacTrac versions: - Reduce to the maximum the number of contours exported to ExacTrac (export to ExacTrac only the contours required for positioning). - Avoid exporting large contours to the ExacTrac, such as table top models. -After each (re) initialization of the ExacTrac application on any workstation, always load first a phantom plane that does not contain outlines. Generate DRRs from that phantom once by selecting the Define DRR Settings tab before loading other patient treatment plans. General reminder: Continue to follow the instructions and warnings described in the User's Guide. In the context of this notification, specifically take into account the relevant safety observations for X-ray correction and verification: - Image overlay functions should be used to verify the accuracy of the fusion in both image views, especially if the images contain a series of similar structures such as the vertebrae. - Do not perform patient treatment unless accurate imaging is possible. - Large correction displacements (eg, greater than 10 mm) may indicate an incorrect automatic melting. In these cases, check the offset offset a second time. - Image overlay functions should be used to verify the accuracy of the fusion in both image views, especially if the images contain a series of similar structures such as the vertebrae. - Do not perform patient treatment unless accurate imaging is possible. - Large correction displacements (eg, greater than 10 mm) may indicate an incorrect automatic melting. In these cases, check the offset offset a second time. "
Causa
According to the company, "a user in the united states has detected that exactrac exhibited the digitally reconstructed radiograph (drr) of the previously uploaded patient data sequence, rather than the correct drr in a later open patient treatment plan. the exactrac application resulting in the correct ddr display. " the company notes that "applying an incorrect displacement can result in a target position of the treatment and the patient in the linear accelerator (linac) different from the intended position. as a consequence, the treatment dose may be applied in a region other than the desired target region. if the deviation exceeds clinically acceptable limits, this may result in ineffective treatment, serious injury to the patient. ".
Acción
Company will send the safety notice (APPENDIX) to the customers and will perform the software revision (ExacTrac v. 6.0.6) with the solution to this problem Field Correction / Software Update - CAPA-20150713-001446.
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 although erroneous uric acid results are not likely to lead to an immediate serious adverse event, a medical risk due to the low false uric acid results in samples with a hematocrit above 48% can not be ruled out.
Causa
After internal evaluation, roche diagnostics gmbh decided to reduce the hematocrit limit value from 55% to a maximum of 48% for reflotron uric acid products for the measurement of whole patient blood samples. during an internal investigation the manufacturer detected deviations in uric acid results in the reflotron system, which may be above the internal specification of 5% if hematocrit values exceed 48%. this may lead to erroneously low uric acid results in whole blood samples with hematocrit greater than 48%. currently hematocrit values are up to 55% for reflotron uric acid.
Acción
The company informs that a note will be added inside the Reflotron Uric Acid box informing about the reduction of the hematocrit limit value to a maximum of 48%. It further states that this information should be taken into account in measurements of whole blood samples from patients
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
Family 2020 monitors (DX2020, DX2021 and DX2023) were identified that restarted during normal use without operator interaction. The reset time lasts about 1 minute and 40 seconds, during which time the monitor does not perform any monitoring or alarm with the patient. On return, the alarm settings are maintained, and the monitor returns to normal operation. This reset, when it occurs, has no set frequency, and may occur within minutes or hours. The cause is in a part of the SBMAME5Kr20 software version code. The conditions that lead the equipment to arrive at this part of the software is not completely defined, and therefore, the company has taken a conservative approach to all products that may present the problem, which are the 233 monitors that have been updated in the field with this version software. There is no evidence, however, that all 233 devices with this release have presented or will fail, but all must have their version updated. Even when there is a low probability of real harm to the patient, when the risk analysis was performed, it was considered that the situation in the field was not acceptable due to the possibility of a more critical situation simultaneously with the time the product can stop monitoring the patient ( 1 minute and 40 seconds), so a mandatory field action has been defined for all products that may present the problem. If the product is used in this situation and the patient has an intercurrent such as cardiac or respiratory arrest during the equipment restart period, intervention and treatment by the hospital's medical staff may be delayed by about 1 minute and 40 seconds, when the alarms would come back to work and attract the attention of the user. As the intended use of the monitor is only in health facilities under the supervision of qualified users (hospital staff), the recommendation is that the use of the monitors should be discontinued immediately and be directed to the necessary corrective maintenance. If it is necessary that they be kept in use for a period of time, it is recommended that these monitors be constantly monitored to identify if the monitor is restarting and, in this case, that the patient is observed directly. Customers with these monitors will receive an informative letter from the company - also available at http://portal.anvisa.gov.br/wps/wcm/connect/5c85be00497425899c679eaccafa2755/Note+of+Aviso+DEDF1527.pdf?MOD=AJPERES. #### UPDATE (09/30/2015): Included software version SBMAME5Kr19 among products at risk.
Causa
Monitor resumes during normal use, without operator interaction.
Acción
Software update (SBMAME5Kr20 and SBMAME5Kr19 versions) by the registry holder to fix the problem.
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
During an internal review, the company identified that the validation data regarding cleaning instructions, sterilization methods and methods defined in the instructions for use of Sureflex Reusable Fibers and their accessories did not meet the new guideline on the qualification of reusable products. The company chose to withdraw the product from the market.
Causa
Validation data regarding cleaning instructions, sterilization methods and methods defined in the instructions for use of the product and its accessories do not meet the new guideline on qualification of reusable products.
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 "elongation of original rupture" requirement of the INMETRO Ordinance nº332, of June 26, 2012. The health services that have the product in stock must segregate the samples so that the holder of the registration proceed with the collection.//// UPDATE ON 03/15/2015: The OCP informed Anvisa that on February 17, 2012, the suspension of the authorization for the use of the Conformity Identification Seal (Ref 00267- 2) .//// UPDATE 03/22/2016: Field Action completed on 1/8/2016, with collection and destruction of the products.
Causa
Suspension of the authorization for the use of the product identification mark (ocp) compliance identification seal caused by the failure to perform the semi-annual maintenance tests in the attribute "original elongation of rupture", according to reports ela / l-264.770 / 15 ( proof) and ela / l-262.651 / 15 (counter-proof).
Acción
Company is performing Field Action for the product. All lots listed in Annex I shall be collected from the market. More information in the Letter to the Client - Annex II.
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 advises the user to "make sure that the Fabius MRI is not moved or positioned in areas over 40mTesla (400Gauss), even at times when it is not used on the patient. Follow all the information and warnings that are in the instruction manual of the equipment. "In addition, users should follow all the information that is presented during installation and training by Dräger training team in Brazil. "During Fabius MRI installations and training the Dräger team in Brazil presents the instructions for use and warnings regarding the product, and in the case of the Fabius MRI the team still sends a letter of recommendation in order to optimize the use and operation of the Fabius MRI and to reduce risks, within the letter is specified that the user must respect the area delimitation ranges: To ensure that the Fabius MRI operate safely and without interference in the proximity of a system for MRI. See attached letter. (Annex 2) In every installation process Dräger delimits the safety area with a yellow stripe with a limit of 40mTesla. According to the attached letter. Annex 2 "(ANNEX)
Causa
The manufacturer dräger has received reports of occurrences in which the fabius mri or parts of the apparatus have been attracted by magnetic resonance magnetic field. if the fabius mri is positioned too close to the resonance equipment, the magnetic force of the mri can loosen fabius mri parts and injure people. according to the company, the operating instructions and the marking of the appliance clearly state that the appliance is to be used only in areas where the field strength does not exceed 40mtesla. according to the company, the reported cases resulted from the fact that the device was moved from the 40mtesla area and the marking of the device while it was not in use.
Acción
The company is alerting users to the possibility of the equipment being attracted by magnetic resonance magnetic field, when displaced from the limit area of 40mTesla (400 Gauss). The company will send a Letter to the clients calling attention to the problem and giving guidelines of the procedures to avoid the problem (APPENDIX). Code PR54354_54316_TSB 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
According to the company, "There is a remote probability of a reversible adverse event during withdrawal of the stainless steel cannula from the abdominal cavity. The crushed plastic part (concave head) detaches itself from the cannula and the surgeon, when attempting to remove the mandrel from the trocar cannula, is unable to withdraw fully and hand contact is necessary in the part remaining in the cavity.
Causa
Traced head of the trocater discharge of the inox canal (mandril) impossibilitando the use during surgical procedure. after investigation and analysis of the materials, a nonconformity with respect to the reported failure was found and concluded that the propagation of process tolerance uncertainties resulted in an excessive residual stress for the material. these tolerances have been adjusted so as to reduce this voltage and prevent premature breaking of the component.
Acción
The company will collect the products at risk, while recommending not to use material from the problem lots. Replacement of defective material by new batch. (Letter to customers in ANNEX Code AI1950
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 clarifies: 1. Only the products listed in the response letter are affected by this recall action; 2.Affected products should be listed in your inventory and segregated in a way that is not used. These products should not enter into clinical use; 3. Disclose to the entire company team this Collection Camp action; 4. Customers must complete the response letter, informing the quantity of products that will be returned and the number of units already used. Inform reference and lot; 5. The Response Letter must be completed and signed and returned by fax, email or post within 10 days of receipt; 4. The response letter must be returned to the company even if there are no units of the product to be returned; 5. Return only the products affected by this Gathering Action. The credit memo will be provided for all returned sterile products; 6. Questions and additional questions related to the return of the products, credit note, replacement or shipment, must be passed to the sales representative of the company or directly to the holder of the registration of the product; 7. If the products have been marketed to another company (s), please send a copy of this information to the company or inform the registration holder of the contact persons; 8. It is fundamental to collaborate with all the distribution chain and use of the product affected by the present action of Recolhimento.
Causa
Problems in the implantation of the sinus superflex-635 stent with a length of 200 mm. partially implanted stents may require additional intervention by a physician due to elongation or fracture of the stent. this recall does not affect patients with a stent of this length already implanted, since the problem that motivated this field action may occur only during the implantation process of this device.
Acción
The company is making a return payment to the manufacturer for the stents of 200 mm length with the following reference numbers / product description (Letter to the clients in ANNEX): (i). 8606-6200 / sinus-SuperFlex-635, Stent System, 6x200mm, 6F / 75 cm, .035i, application device; (ii). 8606-7200 / sinus-SuperFlex-635, Stent System, 6x200mm, 6F / 120 cm, .035i, application device; (iii). 8607-6200 / sinus-SuperFlex-635, Stent System, 7x200mm, 6F / 75 cm, .035i, application device; (iv). 8607-7200 / sinus-SuperFlex-635, Stent System, 7x200mm, 6F / 120 cm, .035i, application device. It should be noted that the reference number and batch number are printed on the labels of the primary and secondary packaging. Take-back / Return action for the manufacturer. Code 15-028
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
SAFETY ALERT: POST should be performed prior to use on patient, as described in the Nellcor ™ OxiMax ® Portable Pulse Oximeters N-65 Operating Manual -65 and Nellcor ™ OxiMax ® N-560 Portable Pulse Oximeters. If during the POST or during the use the absence of any segment in the visualization is observed or if the speaker does not emit sounds, stop the use and contact the company that holds the record. Code FAN65
Causa
Nellcor ™ oximax® n-65 portable pulse oximeters and oximax® n-560 portable pulse oximeters are not showing complete segments of numerical data (see letter to customer), which can lead the end user to misinterpretation of the numerical data. according to emrpesa, the oximetry measurement was not affected, and the problem presented relates solely and exclusively to the numerical demonstration of the display. - letter to clients in annex.
Acción
SAFETY ALERT: POST should be performed prior to use on patient, as described in the Nellcor ™ OxiMax ® Portable Pulse Oximeters N-65 Operating Manual -65 and Nellcor ™ OxiMax ® N-560 Portable Pulse Oximeters. If during the POST or during the use the absence of any segment in the visualization is observed or if the speaker does not emit sounds, stop the use and contact the company that holds the record. Code FAN65
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
SAFETY ALERT: POST should be performed prior to use on patient, as described in the Nellcor ™ OxiMax ® Portable Pulse Oximeters N-65 Operating Manual -65 and Nellcor ™ OxiMax ® N-560 Portable Pulse Oximeters. If during the POST or during the use the absence of any segment in the visualization is observed or if the speaker does not emit sounds, stop the use and contact the company that holds the record. Code FAN560
Causa
Nellcor ™ oximax® n-65 portable pulse oximeters and nellcor ™ oximax® n-560 portable pulse oximeters are not showing complete segments of numerical data (see example in the customer letter), which can lead the end user to a misinterpretation of numerical data. the company points out that the oximetry measurement was not affected, and the problem presented refers solely and exclusively to the numerical demonstration of the display. - letter to clients in annex.
Acción
SAFETY ALERT: POST should be performed prior to use on patient, as described in the Nellcor ™ OxiMax ® Portable Pulse Oximeters N-65 Operating Manual -65 and Nellcor ™ OxiMax ® N-560 Portable Pulse Oximeters. If during the POST or during the use the absence of any segment in the visualization is observed or if the speaker does not emit sounds, stop the use and contact the company that holds the record. Code FAN560
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
Before the publication of the RE, the services that have the product in stock should contact the company to make the payment.
Causa
Proof of manufacture / commercialization of gravitational infusion equipment and for use in infusion pump without filters, in disagreement with what is determined by the norms abnt nbr iso 8536-4: 2011 and 8536-8: 2012 and resolution rdc 4/2011.
Acción
The company must perform the Recollection of the products made available in the market, as determined by resolution RE 2.174 / 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
According to the company's statement, the interference of the drugs N-acetylcysteine (NAC), acetaminophen (acetaminophen) and metamizole (dipyrone) is related to the occurrence of falsely low test results using the Trinder reaction, when sample collection to perform the tests is performed immediately after the administration of the same.
Causa
Biosys ltda., the holder of the registrations of the above mentioned products, received a communiqué from the international manufacturer, diasys diagnostic systems gmbh, informing that the products that use as a methodology the reactions called trinder, suffer interference due to the following drugs: n-acetylcysteine (nac), acetaminophen (acetaminophen) and metamizole (dipyrone) given in therapeutic doses. trinder's reactions are based on a color reaction in which the hydrogen peroxide (h2o2) is formed and subsequently reacted with amino-antipyrine (a phenol derivative) and peroxidase as the catalyst. peroxidase reactions have been observed to undergo interference to varying degrees by the drugs mentioned. the products cited use the trinder reaction as a methodology. biosys informs that it has not been notified until the moment of occurrence related to this interference in national territory.
Acción
The company recommends blood collection before administration of the following drugs: N-acetylcysteine (NAC), acetaminophen (paraceamol) and metamizole (dipyrone), when testing for the following analytes: Cholesterol, Glucose, HDL, Triglycerides and Uric Acid, which use in their methodology Trinder reactions (products and numbers of registries listed - Annex I). The company made the information available on its website. Further information check: Annex II - Notice to the Client and Annex III - Distribution Map
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's statement, the loss of intraocular fluid through a cannula or sclerotomy during surgery can cause fluctuations in intraocular pressure. To avoid changes in intraocular pressure (IOP), use of the IOP control feature of the CONSTELLATION® Vision System can be used during surgery, or a plug can be inserted into the valve cannula.
Causa
The company alcon has identified that some specific batches of valve cannulas have the possibility to leak through its format. the product is sold as a single item or as part of the constellation® equipment kit.
Acción
The company that holds the registration in Brazil will take corrective action providing individual plugs to be used with the valve cannula, in cases where an excessive leak is identified during the use of the affected kit. For more information, contact the company. Phone: (11) 3732-4023
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
0
Causa
Analysis report nº 230.00 / 2015 issued by lacen sc, with an unsatisfactory result in the appearance and labeling parameters.
Acción
The company that holds the registration in Brazil is paying the product. Company directs you to discontinue use and contact Manufacturer for return, telephone: (47) 3379-2310
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 resolution also determined that the company promotes the collection of existing stock in the market for the products cited.
Causa
Products manufactured in chromium-cobalt alloy, but labeled in brazil as being manufactured in titanium.
Acción
Published Resolution RE 1,051 of April 6, 2015, determining the suspension of the distribution, commercialization and implantation of the aforementioned products, manufactured in Chromo-Cobalt alloy by the company Groupe Lepine, France, imported and re-labeled as being manufactured in Titanium.