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 when an affected S2 Fluid Pack is inserted into the cobas b 221 instrument, it will display the error message "Transponder error" and the instrument can not start the measurement until the affected S2 Fluid Pack is replaced by a packaging that does not present a defect and may lead to a delay in the measurement of the parameters. If the equipment correctly identifies the package, the measurement will proceed normally as there are no problems with the reagent.
Causa
Roche diagnostics gmbh, the manufacturer of the products involved in this notification, after internal investigations identified a possible increase in the generation of transponder errors specific to s2 fluid pack reagent packs from lots 21450781, 21450887 and 21451391. such an error is detected and generated by equipment as soon as an affected s2 fluid pack is inserted, making it impossible to use it. the company informs that not all packs of fluid pack from these batches have been affected and the only way to identify whether or not the product is affected is by inserting the fluid pack fluid pack into the instrument and checking if an error message is indicated.
Acción
The company advises that: i) S2 Fluid Pack packages should be replaced if "Transponder error" is indicated. The affected Fluid Pack packaging must be disposed of locally. ii) In case the customer finds the message "Transponder error", we request that you contact our service center CEAC - 08007720295 for treatment of the occurrence.
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 purpose of this communication is to prevent occurrences of product breakdown.
Causa
The company informs that the release mechanism of the torque switch supports the application of a defined force of 2.8nm. if the applied force is greater than the defined force, the screw break may occur. the torque wrench is made up of three parts and can be dismantled for cleaning. assembly and disassembly of the torque switch are described in the product use manual.
Acción
The company instructs you to follow the assembly and disassembly instructions described in the Product Use Manual and detailed in the Appendix - 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
According to the information of the holder, in the event of cable breakage and failure of the rubber safety lock, the assembly may slide along the column without speed control, depending on the degree of elevation. In this case the patient under procedure would be exposed to the risk of an adverse event. #### UPDATED ON 07/18/2017, the company sent a report of completion of the field action proving the accomplishment of exchange, as planned.
Causa
According to the record holder, there is a possibility that the steel cable component, used to lift the suspension mass of the arm assembly, x-ray tube and collimator, can break after a period of heavy equipment use due to the continuous contact with some mechanical parts inside the stationary (spring or motorized) column.
Acción
The company issued two safety notices. For customers who received the 001 (FSN) notice, the recommendation is to discontinue use of the equipment and wait for a preliminary inspection of the cable for action by the field engineer. For customers who received the 002 (FSN) communiqué, the equipment will not need to be interrupted and customers should wait for the scheduling of the service by the field engineer to exchange the parts involved
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
Sulfasalazine and Sulfapiridine may lead to potentially poor / high ALT, AST, CK-MB, GLDH, and NH3 testing in NAD (H) or NADP (H) ) in the reaction, which may lead to a delay in the decision of the medical evaluation.
Causa
Roche diagnostics gmbh, a legal manufacturer of the products involved in this alert, made changes to the session of interfering with the use of nad (h) or nadp (h) tests (alt, ast, ck-mb, gldh and nh3), warning of possible drug interference of sulfasalazine and sulfapyridine. these changes were made in 2014.
Acción
At therapeutic concentrations, Sulfasalazine and Sulfapiridine may lead to potentially inadequate low / high ALT, AST, CK-MB, GLDH and NH3 tests in NAD (H) or NADP ( H) in the reaction; The abovementioned test results may be inadequately low / high when the blood sample is collected in the presence of Sulfasalazine and Sulfapyridine in the patient's blood. • Physicians should be advised that patients currently receiving Sulfasalazine and Sulfapiridine may receive possible false results of ALT, AST, CK-MB, GLDH, and NH3. Further information - Annex II Letter to the Client and Annex III List of Customers
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
A leak in the water circulation circuit may result in short circuit in the equipment, with risk of abrupt shutdown during a surgical procedure. It is recommended not to use the equipment under risk, until the company corrects it.
Causa
Potential leakage in the water circulation circuit.
Acción
Field correction for replacement / repair of equipment parts.
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 a possibility of collision of the linear accelerator gantry with the patient or the treatment table.
Causa
When the equipment is switched on, it checks if the position of the gantry has changed when the equipment has been switched off. in some cases, it has been identified as changed, even though it has not been changed since the shutdown. in these cases, the console display starts to flash.
Acción
The company that holds the registry will do an update of the control console software to version 11.0.400
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 holder due to the problem in the conductive material, measurement errors may occur at the level even though there is the minimum volume of sample present in the sample cup or tube. . An error message may appear if there is not enough sample in the microsample tube or sample cup
Causa
The conductive material of the immulite / immulite 1000 sample cup holders and the immulite 2000 / immulite 2000xpi microsample inserts, both used for sample processing, do not meet the specification to facilitate measurement of the liquid and sample level respectively (sensor error). level).
Acción
According to the holder of the registration, for IMMULITE / IMMULITE 1000 the problem can be solved by adding more sample to the sample cup. For IMMULITE 2000 / IMMULITE 2000XPi the problem can be solved by adding more sample to the micro-sample tube. The company will make a field correction of the analyzers with replacement of the units. See affected lots in the ANNEX. Upon receiving the new sample cup Holder or microsample insert discard the products from the problematic lots.
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
Cannulated macheters are surgically used to prepare the anatomy of the spine for screw placement. They can be used with guide wires to aid placement. If they are not used with guidewires, the bone material may accumulate in the lumen of these devices. If cleaning the macheter is not done properly and in accordance with the instructions in force for cleaning, the bone material will harden, causing difficulties in subsequent cleaning. If the cleaner uses a sharp instrument in an attempt to remove buildup of bone tissue, injury may occur if no precaution is taken. It is recommended to use the guidewire during the surgical procedure and to be careful when cleaning the macheadores if sharp instruments are used. If the obstruction in the cannula can not be removed, the instructions for use indicate that the devices should be considered at the end of their useful life and should be discarded according to the installation procedures and guidelines. A copy of the updated instructions for use will be sent to the customer, as informed by Medtronic Comercial Ltda. This field action involves two distinct registers, but it is the same product. The field action will be carried out by Medtronic Comercial Ltda.
Causa
Use of the mats without the guidewire can lead to an accumulation of bone or other tissues in your cannula, which can result in injury to users of the product when cleaning the device.
Acción
Changing the directions for use of the product to clearly detail the potential for bone / tissue accumulation in the product cannula (especially if used without the guidewire) and warn the user of the risk of injury while cleaning the device.
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 Artis system may not move on its own initiative and the movement initiated by the operator. However, when moving, the speed of the system may be higher than usual and cause collision.
Causa
Position sensor failure in the hinged base shaft that is not detected by the system software. the c-arm system can move, unexpectedly, faster than normal.
Acción
The company that owns the registry will update the software. The recommendation, as long as field correction is not performed, is for customers to continue to use the system.
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 following factors may have a significant effect on the overall navigation accuracy of the device: (1) Large distance between the reference star and the region of interest; (2) Large changes in camera positioning relative to the reference star during the procedure. Such occurrences may intensify small inaccuracies resulting from specific steps of the complex navigation procedure. In the worst case scenario, such inaccuracies may result in inaccurate display of the instruments by the navigation system, compared to the actual anatomy of the patient. Brainlab has released a new version of Brainlab Cranial software (version 2.1.2) to fix the problem. Until the new software is installed, users of the product should follow the instructions already provided by the company "Measures to Improve the Precision of Skull Navigation" and read the warning message issued by the company for this field action.
Causa
Certain occurrences may intensify inaccuracies in the system, which may result in inaccurate display of the instruments by the navigation system compared to the actual anatomy of the patient.
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 flaw can cause left-right inversion in the images with incorrect guidance annotations. #### Update of the field action: UPDATED ON 10/23/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
Causa
No spacer on the x-axis gradient cable used in acgd mr cabinet to prevent connection with incorrect polarity.
Acción
The company will fix the problem in the field and instruct customers to continue to use the device in accordance with current maintenance procedures. It is important that the Service Engineer perform the geometry check after the maintenance of your system. This scan will detect 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
Report of Analysis OS nº 115.50743, referring to the product Surgical Compresses of Hydrophilic Gauze, manufacturer América Medical Ltda, Lot 0623, with unsatisfactory report, resulting in precautionary interdiction of the product by Sanitary Surveillance.
Causa
Foreign body identification inside a sealed envelope with 10 product units.
Acción
The company advises customers to carry out product segregation. Subsequently, the product will be collected. In case of other deviations of quality referring to this batch, the company must be communicated.
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
Immediate Protective Action - Customer Guidelines: • Use only an empty microplate for balancing purposes. For example: when only one microplate is read; • Check the color of the results presented by the Maestro software during validation; • Do not validate results if well images appear in black and white.
Causa
It has been shown that in exceptional circumstances, the lyra ii agglutination reaction reader software (ms registry 80004040165) may incorrectly attribute the result of a microplate previously read to the microplate being processed. when this occurs, incorrect results are displayed in black and white instead of colored. according to a company risk assessment, "the likelihood of reporting an erroneous outcome is very limited, since the occurrence of this event is associated with several random factors occurring simultaneously. to date, no incident with patient has been reported.".
Acción
Company is informing its customers about the problem so that they take the appropriate preventive measures until a definitive solution is released through a new software version. It is reported that "the probability of reporting an erroneous result is very limited, since the occurrence of this event is associated with several random factors occurring simultaneously." To date, no incident with patient has been reported. "; Action: Update, correction or supplementation of the instructions for use Code: AC 2015/02 SEE ATTACHMENTS: (i). Important Notice of Field (AC) - AC Number: 2015/02; (ii) .CORRECTIVE ACTION NOTIFICATION ACKNOWLEDGMENT (AC 2015/02)
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 health impact is dependent on the clinical application in which the Gama Wizard² counter is being used. The applications are: gamma count measurement, radioimmunoassay tests, determination of glomerular filtration rates and dose determination of radiopharmaceuticals in nuclear medicine.
Causa
Error in the contents of the second bar code of label no. 23. the label is being incorrectly identified as #. 24 when scanned.
Acción
The company that holds the registration guides the immediate destruction of all barcode labels. 23 that are in the possession of the clients. The Wizard2 Gamma Counter contains a total of 20 bar code labels identified as # 23 (ie, 02 labels on each of the 10 pages). Be sure to inspect all sample racks to remove and destroy all # 23 bar code labels already attached to the racks.
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.