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 record holder there is a possible fault in the monitor stator actuator assembly. failure to do so may cause the monitor to drop and possible collision with other parts of the equipment, professional or patient.
Acción
The record holder's recommendations are to not position or move the monitor ceiling suspension above the patient; do not allow the staff to remain below or near the ceiling suspension of the monitors and to avoid unnecessary ceiling suspension movements.
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
Other clarifications from the company regarding the problem encountered are: - While recovery with patient samples for batches of individual kits continues to meet Siemens' quality control specifications, it has been observed that lot 311 at the lower limit and lot 312 at the upper limit of the curve, are resulting in higher than expected values due to the difference between the two kits. - When comparing lot 312 with lot 311, Siemens observed a mean bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 U / mL and an average of 5% bias (range of 1% to 11%) for patient samples recovering from 540 to 660 U / mL. In future batches of kits, recovery of Quality Control and patient samples similar to lot 312 are expected. - The health risk is related to a delay in the test if the laboratories choose not to perform the test for more than one month. It is limited to a potential delay in radiographic tests if the biochemical tests indicate the recurrence of the disease. If the labs continue with the test, there may be a potential for additional radiographic examination. However, this will not lead to a health risk.
Causa
Positive bias for the bio-rad lyphochek® tumor marker plus control and the bio-rad liquichek ™ tumor marker control, when used in conjunction with batches 312 and 313 of the immulite 2000 / immulite 2000 xpi gi-ma assay (ca 19 -9). the appearance of the bias was due to the introduction of a new batch of murine monoclonal antibodies to the batch 312 kit. the bio-rad lyphochek tumor marker plus and liquichek tumor marker controls were redefined for the immulite 2000 / immulite 2000 xpi gi-ma kits (ca19-9), lots 312 and above. in addition, a larger than expected change in patient sample retrieval can be observed when migration of kits lot 311 to lots 312 and above occurs.
Acción
According to the registry holder, if lot 311 was used, Siemens recommends considering new patient monitoring using the GI-MA IMMULITE 2000 / IMMULITE 2000 XPi kits, lots 312 and above. It is also advised to keep the letter of the Urgent Field Safety Notification along with the laboratory records. //// Review of previously released results is not recommended. //// If the patient was monitored using lot 311, consider a new monitoring using lots 312 and above. (SEE ATTACHED)
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the registry holder, there is a serious accident for the patient and operator / technician resulting from the problem: "For the patient: • There is a possibility of disconnection or movement of invasive medical devices. For the Operator / Technician: • There is a possibility of there are compression / crush points in the substructure; and • A possibility of retention between the table and the gantry if the Operator / Technician positions between them to move the patient forward.
Causa
Considering that the maintenance latch is secured and the stem of the maintenance latch is broken, the tabletop can float freely, causing an involuntary horizontal movement.
Acción
The company directs the operator to notice a horizontal free floating movement of the table during normal clinical use, immediately stop using the system and contact your Maintenance Engineer. It is important to keep the Safety Warning with the Instructions for Use (IFUs) 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
The registry holder informs that the occurrence of the failure can generate a sudden change in speed and / or direction of the treadmill, with possibility of falls and injuries in patients. The risk of movement of the canvas increases on the larger inclines of the treadmill. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
Causa
Treadmill performance failure due to loss of commutation (required for proper motor operation), which can cause uncontrolled movement of the canvas during a stress test exercise. this movement can be observed as an unexpected deceleration, followed by a sudden acceleration of the canvas, forward or backward. when this occurs, the treadmill will not stop immediately after pressing the emergency stop button (estop).
Acción
According to the record holder, "if any uncontrolled movement of the tarpaulin, including unexpected stop, deceleration, acceleration or change of direction, is observed while the patient is on the treadmill, the health professional should: • Press the Stop button • Instruct the patient to: - Hold the handrails to help maintain balance - Exit the canvas by placing the feet on the non-slip rubberized sides that are on the sides of the canvas - After the treadmill stops instruct the patient to get off the treadmill. Depending on the speed of the canvas, a complete shutdown can take up to 35 seconds. • If any uncontrolled treadmill movement is observed, discontinue use of the T2100 treadmill and contact GE Healthcare.
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 may be due to non-preventive maintenance or periodic battery replacement. The risks involved in the failure of the device are: chemical or thermal burns and irritation in the eyes, nose or throat. #### UPDATED 7/18/2017, the company sent a field action completion report, foreseen.
Causa
Ups devices fail (uninterruptible power supply) resulting in battery acid leakage, overheating or smoke emission. all ups devices with lead acid batteries are susceptible to this problem.
Acción
According to the registration holder's instructions, the customer should analyze the contents of the folder and implement a UPS maintenance program as recommended by the manufacturer of his UPS. /// If you notice any unusual odor and / or heat, or see any liquid in the UPS area, do not touch the device or the surrounding liquid. Follow your institution's procedure for potentially hazardous materials. Inform all persons in the vicinity of this potentially dangerous situation, including but not limited to - patients, staff and maintenance personnel. Contact your service provider immediately.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the registry holder, there was an accident report of the equipment with an operator. The accident resulted in an injury to the operator.
Causa
Collimation cassette misalignment on upper guide bearings when manual override causes collimator to drop and cassette.
Acción
According to record holder guidelines, if the customer visually identifies a misalignment at the top and / or bottom of the guide rail between the cabinet and the car, the collimator replacement procedure should not be continued. The misalignment problem can only be solved during a maintenance operation.
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 make a new label containing the correct temperature information. Using the product outside the correct temperature conservation decreases the effectiveness and safety of the results.
Causa
Labeling error with regard to storage / storage temperature. correct temperature of 2-8 ° c; temperature labeled 18-25 ° c.
Acción
The registration holder guides the follow-up of the instructions for use with regard to the temperature conservation of the product.
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
Actions to be taken by the customer / user, according to the company: • Customers must stop using the affected product (affected batches), eliminating it locally and switching to subsequent batches of HCYS that are not affected: Batch Affected: 69780301 / 69781101/69781401 - Expiry date30 / 04/2015 - Using Subsequent Batches: 607116101/60716801/60717101 - Validity 1/31/2016
Causa
The company reported that "customers complained of a 20% decrease in control levels when using non-roche controls (eg, thermofisher liqimmune) with the reagent homocysteine from lot 697811 on cobas c 501 equipment. lot 604303, controls were within range. comparison of patient samples with reagent lot 697811 versus lot 604303 showed a deviation of up to 54%. plasma samples were used in edta. this negative deviation could result, in the worst case, in low homocysteine results. however, it is unlikely that inaccurately low homocysteine results could have caused an immediate adverse event, since homocysteine has been shown to be an indicator of long-term cardiovascular risk (late cardiac events) rather than short-term events. ".
Acción
Company communicated its customers by letter (LETTER IN ANNEX) Type of action: Notice to Customers and Distributors not to use affected lots (LETTER IN ANNEX) /// Code: SBN_RPD_2015_006
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 customers to segregate the material so that it is collected
Causa
Suspension of authorization for use of the conformity identification seal product certification body (ocp), once the product was disapproved in the annual maintenance tests, which presented non-compliance with iso standard 11.193-1 / 09.
Acción
Company is carrying out Field Action for the collection of manufactured 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 company clarifies that the use of the affected equipment may cause the procedure to be suspended due to the shutdown defect mode of the monitor, requiring an alternative technique during the procedure if the monitor turns off and does not allow viewing.
Causa
Vr medical informs that, through a statement issued by sony brazil, it was informed of the need to replace the power plate of the anvisa 80102510940 lcd monitors. this need arises from the fact that the monitors do not turn on or lose the image during the clinical use. according to manufacturer's investigation the problem is due to a disconnection of the internal power supply caused by failure in the integrated circuit of the power board. it was reported that up to now in brazil there have been no reports of adverse events associated with this mode of defect.
Acción
The company directs users who own affected equipment to follow the guidelines outlined in the SONY Communiqué: 1) If you have an AC adapter (AC-110MD) for each of your affected monitors, only use the AC adapter when the monitors are in use; 2) If you do NOT have an AC adapter (AC-110MD) for each of the affected monitors, stop using the operation monitor until the permanent corrective measure is deployed. For more information, access the appendix Customer Information - Sony LCD Monitor
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 risk assessment carried out by the company, the SEVERITY of the potential consequences for patients of incorrect or delayed results may be considered CRITICAL, which may lead to permanent deterioration, high impact on the patient's health or even death . The probability of occurrence was determined by the company as OCASIONAL, which means "possible to occur a few times during the product life cycle." The general risk posed by the company is MODERATED in a general way. relevant in Brazil since Flucitosycin is not used as therapy in case of fungemia (as it appears in the technical literature available in the market).
Causa
During the quality control tests to be performed by the clients, it was identified that strain atcc 6258 - candida krusei, naturally resistant to the antibiotic flucitosina, presented results outside the minimum range required for such antibiotic, which means a sensitive result for flucitosina.
Acción
The company has already started communicating with its customers, alerting to the problem in question and is developing a new formulation for the product, which should be available within 6 months. Identify if you have products at risk in stock and carefully read the letter disclosed by the company, to take the necessary steps - letter available at http://portal.anvisa.gov.br/wps/wcm/connect/bae52680481c317688dfadbdc15bfe28/Notifica%C3 A + A + + + + + + + + + + + + + + + + + + + + + + + A9rieux.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 record holder, if pipeline dislodges, insulin delivery is interrupted and the pump will not alarm. The consequences of this failure may culminate in hyperglycemia, which if left untreated may result in diabetic ketoacidosis (DKA). For a detailed description of the problem and handling instructions relevant to users of such infusion sets, the registrant requests the attached manufacturer's communication. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
Causa
According to the registry holder there are reports of disconnection of the tubing at the site of disconnection / connection of the infusion system.
Acción
The company made a Notice to customers and guides the user, in case the tube feels loose: 1. Do not try to reconnect the tube. Immediately replace the infusion set. 2. Treat high sugar levels as directed by your healthcare professional. 3. Tell your distributor's Hotline to record the occurrence. You will be given instructions on how to return the affected infusion set. For infusion system users, following the advice below. 1. When changing your infusion set, carefully follow the "Instructions for Use" included in the package. Check the tubing at the connection / disconnection location identified in the drawings above to ensure that it is not loose. 2. Monitor your blood glucose levels with the glucose meter. Proactively control tubing connections occasionally during the day to ensure it is securely attached. It is especially important to monitor your blood sugar levels and tube connections before bedtime to confirm that insulin is being administered. 3. If your sugar levels are elevated, carefully check the tube connections and infusion site to ensure the tube is secure.
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, non-compliance of thickness was found in the wrist.
Causa
The gloves presented nonconformity in the semester evaluation of quality performed by the falcão bauer institute of quality. the test reports are: ela / l-25.871 / 3/4/14 and ela / l-256.453 / 1/2/2015.
Acción
The company that holds the registration informs that it will make the exchange of the product due to the disapproval.
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 the "segregation of products from lot 0573, for collection, if there are products of this lot still in stock. If there are new reports of quality deviations, referring to this lot 0573, immediately inform America Medical. "
Causa
Presence of foreign body in a sealed unit of the product.
Acción
COVISA São Paulo determined the payment according to COVISA NOTICE No. 015/2015 (APPENDIX). The company will collect the product (Return to the manufacturer). Code 001/2015
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 registry holder, there is a low probability of this failure resulting in the breaking of the equipment bearing, which causes the arm to tilt about fifteen degrees toward the patient. If the event occurs during the examination, there is a risk of injury to the patient.
Causa
Product received with broken bearing weld.
Acción
For safety reasons, according to the manufacturer, if the problem is detected in the equipment, an immediate suspension of use will be requested and the customer must request a repair appointment for the equipment by a qualified technician.
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 filed a request to change the registry.
Causa
Discrepancy between the sterilization certificate and the sterilization method reported in the registry.
Acción
The company holding the registration forwarded a notice to all distributors of the product informing them not to release new import orders until the modifications in the registration are approved and published by Anvisa and quarantine the products in order not to distribute and market the stocks.
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 risk is related to a potential correction of up to 5% in the sodium parameter, which may generate a lower result than expected
Causa
Presence of positive bias, possibly above 5%, which may result in unnecessary fault or correction in dilution check. dilution check failure prevents the complete installation of the quiklyte integrated multisensor.
Acción
According to the registry holder, customers were advised of the following recommendations: • Discontinue use and discard the product from the batch involved. • Review the letter with the laboratory officer. • Review inventory / inventory of this product to determine replacement requirements. • Complete Field Action Effectiveness Check Form. It was not recommended to review the results previously generated by the laboratory.
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 stability specifications of the opened bottle in the Instructions for Use written in Portuguese do not apply to lot 33505140.
Causa
02 problems were recorded: incorrect instruction resulting in an error in the stability specifications of the open bottle; the process of suitability was carried out outside the appropriate temperature conditions, i.E. at a temperature of -20 ° c or below. the consequence of subjecting the product to a partial freeze-thaw cycle is the change in its performance.
Acción
The registration holder advises customers to discontinue use of the product in accordance with laboratory procedures and forward letter to the company to arrange for the product to be collected.
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
Equipment with incorrectly mounted modules may be affected. The effect is to display a high SpO² value in the monitoring device when a low SpO² value is measured. The opposite can also occur, ie high SpO² measured value and the value displayed on the monitor is low. The oximetry modules provided after 10/22/2014 are not affected by the problem.
Causa
Some oximetry modules have been fitted incorrectly.
Acción
The record holder's recommendations are for customers to evaluate the oximetry cable inventory using the method described in the safety notice (SEE APPENDIX).
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 during an interventional procedure, there is a risk of serious injury to the patient if the clinician does not have the real-time feedback of the needle placement when it is close to the vital structures (large vessel, organ, etc.). .). #### UPDATED ON 07/18/2017, the company sent the completion report of the field action proving the accomplishment of correction, as planned.
Causa
According to record holder information, "during the conduct of the tcc in the ingenuity ct system, the first image was marked as" last capture "instead of the current" last capture "acquired. by pressing the pedal for the first exposure, the images were displayed as the "last shot". subsequent requests did not result in an immediate reconstruction of the image and the first image remained on the screen identified as the "last capture". eventually all images appeared. the problem is caused by incorrect settings for increasing the number of slices in the user set for the tcc protocol resulting from the conversion of the protocol to the exam card during software upgrade from v3.X to v4.0.0 / v4.0.1. in normal tcc mode, the images are reconstructed without delay and the "last capture" is displayed properly with the last reconstructed result. ".
Acción
The record holder's recommendations, affected users should check the TCC examination card and correct it if this problem exists. The guidance is to refer to the steps in the Addendum to the safety notice (see 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 a consequence of blocking the database, the interpreting physician may not notice the absence of images following the examination, and may therefore provide, suspend therapies, delay treatment or perform interventions based on incomplete information. /// The GEHC informs that this field action does NOT have units imported or distributed in Brazil and, because it is of great relevance, we formally express this negative. There will be no product safety card for the reasons given. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
Causa
According to information from the registry holder, a database lock may occur during the image acquisition process, affecting the integrity of the acquired images. if the database lock occurs, there is a possibility that one or more images may be missing in the exams. examples of circumstances that may contribute to database crashes include: high number of concurrent users, high number of image acquisition sources, high image count, multiple users modifying studies before receiving all images, and constant requests for access to the database.
Acción
Here are the registration holder's guidelines for the problem: "Until software update is available to correct this problem, the following actions are recommended for the user: 1. Use image counter within the QC process, to alert the user about discrepancies between the number of images transmitted by the mode and the number of images available in the PACS IW viewer. The. If a discrepancy is detected, try retransmitting the exam to the PACS. B. If retransmission fails, a GE Healthcare Technical Assistance representative should be contacted to provide assistance in resolving the affected examination. Urgent cases affected by this problem should be interpreted in the modality. 2. If DICOM storage confirmation is configured and in use, images that are impacted by this issue will not send confirmation notification to the mode. 3. Pay attention to the previous cases, acquired prior to the application of the safety instructions provided in this release, as these cases may have been affected by this security problem. For questions about history data, contact GE Technical Assistance for assistance in identifying any affected images. "
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 risk that D-fend condenser units in the field are defective. These defective units can lead to delays in the measurement of CO2, O2 and anesthetic agents. The measurement of CO2 is important both in the Operating Rooms and Intensive Care Units (ICUs) so that the measurement of patient ventilation is possible. When this problem is detected by the equipment, the connected monitoring device will issue an audible alarm and will display the following warning messages: "low gas sample flow", "replace water trap" condenser) or "sampling line blocked". Ignored or prolonged alarms can lead to an adverse outcome if the CO2 value changes rapidly in certain clinical conditions. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
Causa
Occlusion, of specific batches, of the condensers of humidity d-fend / d-fend +. this failure may occur immediately after a replacement. occlusion of the moisture condenser can cause a loss of airway respiratory gas monitoring.
Acción
The record holder recommends identifying the affected and unaffected products. The user must check the moisture capacitors through the batch number to identify the affected units. The batch number can be found in the cartons (white label in the box) and the individual moisture capacitors (white label on the front). Affected lots: D-Fend (Part Numbers): 876446-HEL: J9964985, J10201698, J10258248, J10284871, J10284872, J10344108 D-Fend + (Part Numbers): 881319-HEL: J9906966, J9965152, J10258251, J10300071 /// - Moisture condenser boxes with the batch numbers specified above without the Green Point Adhesive are affected. - Moisture condenser boxes with the batch numbers specified above with the Green Point Adhesive next to the batch number are not affected. If the lot is not affected, these products may remain in use / stock. / / In case the lot is affected, the user must: 1) Collect and discard all affected moisture capacitors. 2) Complete and return the Medical Device Correction Confirmation form attached to the Urgent Security Notice Letter. Detailed instructions SEE WARNING 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 company recommends "DISCONTINUE USING THE PRODUCT".
Causa
Dilution (ref 004033) batch 50870.29.02 and id-dat igg - dilution (ref 004033) batch 50870.30. dilution of product reactivity, identified by means of the monitoring of the stability performed in samples of retention of id-dat igg. 01. according to the company, "the division mentioned can affect the evaluation of the hemolysis risk in the following situations: • monitoring the patient with hemolytic anemia auto-imune (aiha) • monitoring hemolytic disease in newborns • other investigations for dat positives considering used laboratory practices and the intended use of this product, the results obtained from this product should not be considered isolately but associated with the patient's clinical condition, his medical history, in addition to other relevant laboratory data. in the instruction for use accompanying the product ".
Acción
The company is communicating its clients (IN THE ANNEX LETTER TO THE CLIENTS AND MAP OF DISTRIBUTION) and carrying out the Recolhimento for the destruction of the lots under risk in Brazil. Code: AC 2015/01
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
Dropping the arm may result in patient injury, operator or loss of interventional imaging.
Causa
According to the information of the registration holder during movement of the shaft / flange joint the arm assembly c disconnects and may fall.
Acción
The company will correct the affected parties. It is recommended by the holder that the establishments stop using the Angix system until an inspection is performed by XPRO.
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 possible consequences of the failure are: 1) Potential marking in the Cornea due to Suction Loss; 2) Incorrect Cataract Incision Mode Potential by Surgeon.
Causa
According to data from the registry holder, 2 questions related to the catalys® system software version 3.00.05: 1 were identified; being: 1) loss of suction during treatment may lead to a marking of the cornea, during crystalline fragmentation; 2) change in cataract incision mode with software in version 3.00.05. selecting and deselecting one eye and then selecting the other eye will result in modes with the same parameters for both eyes.
Acción
The company directs: A) continuously monitor the video image immediately before and during each laser treatment, looking for blisters or other indications of loss of suction. If a blister or abnormality is observed, remove the foot from the laser pedal immediately to stop the treatment. B) Check that the LIQUID OPTICS Interface remains completely filled with sterile balanced physiological solution throughout the procedure. If the CATALYS® System detects forces out of acceptable levels or loses suction during laser treatment, follow the instructions for continued treatment as described in the Operator's Manual or consider switching to traditional cataract surgery. If the laser treatment has not yet begun, check the fluid collection and consider reapplying the suction ring to the patient's eye. C) Verify that the cataract incisions in the cataract incision models by the surgeon have the correct parameters, the correct architecture and are in the desired location before saving. D). During the treatment planning phase and before activating the laser, check that all treatment incisions have the correct parameters, the correct architecture and whether they are in the desired location shown on the screen.