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Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: d1: heartware ventricular assist system ¿ battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2023 / serial or lot#: (b)(6), udi #: (b)(4), d9: yes, return date: 13-jun-2023 h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.H4: mfg date: 29-sep-2022, h5: no, h6: patient ime code(s): e2403, h6: imf code(s): f26, h6: img code(s): g02002, h6: fda device code(s): a0705, h6: fda method code(s): b21, h6: fda results code(s): c21, h6: fda conclusion code(s): d16; d1: heartware ventricular assist system ¿ battery, d4: model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2023 / serial or lot#: (b)(6), udi #: (b)(4), d9: no, h3: no, device evaluation anticipated, but not yet begun, h4: mfg date: 29-sep-2022, h5: no, h6: patient ime code(s): e2403, h6: imf code(s): f26, h6: img code(s): g02002, h6: fda device code(s): a0705, h6: fda method code(s): b21, h6: fda results code(s): c21, h6: fda conclusion code(s): d16; d1: heartware ventricular assist system ¿ battery, d4: model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2023 / serial or lot#: (b)(6), udi #: (b)(4), d9: yes, return date: 13-jun-2023, h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes, h4: mfg date: 29-sep-2022, h5: no, h6: patient ime code(s): e2403, h6: imf code(s): f26, h6: img code(s): g02002, h6: fda device code(s): a0705, h6: fda method code(s): b21, h6: fda results code(s): c21, h6: fda conclusion code(s): d16, d1: heartware ventricular assist system ¿ battery, d4: model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2023 / serial or lot#: (b)(6), udi #: (b)(4), d9: yes, return date: 13-jun-2023, h3: no, device evaluation anticipated, but not yet begun, dev rtn to mfr? yes, h4: mfg date: 29-sep-2022, h5: no, h6: patient ime code(s): e2403, h6: imf code(s): f26, h6: img code(s): g02002, h6: fda device code(s): a0705, h6: fda method code(s): b21, h6: fda results code(s): c21, h6: fda conclusion code(s): d16; d1: heartware ventricular assist system ¿ battery, d4: model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2023 / serial or lot#: (b)(6), udi #: (b)(4), d9: yes, return date: 13-jun-2023, h3: no, device evaluation anticipated, but not yet begun, dev rtn to mfr? yes, h4: mfg date: 29-sep-2022, h5: no, h6: patient ime code(s): e2403, h6: imf code(s): f26, h6: img code(s): g02002, h6: fda device code(s): a0705, h6: fda method code(s): b21, h6: fda results code(s): c21, h6: fda conclusion code(s): d16, d1: heartware ventricular assist system ¿ battery, d4: model #: 1650 / catalog #: 1650 / expiration date: 30-jun-2023 / serial or lot#: (b)(6), udi #: (b)(4), d9: no, h3: no, device evaluation anticipated, but not yet begun, h4: mfg date: 29-jun-2022, h5: no, h6: patient ime code(s): e2403, h6: imf code(s): f26, h6: img code(s): g02002, h6: fda device code(s): a0705, h6: fda method code(s): b21, h6: fda results code(s): c21, h6: fda conclusion code(s): d16; d1: heartware ventricular assist system ¿ battery, d4: model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2023 / serial or lot#: (b)(6), udi #: (b)(4), d9: no, h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 29-sep-2022, h5: no, h6: patient ime code(s): e2403, h6: imf code(s): f26, h6: img code(s): g02002, h6: fda device code(s): a0705, h6: fda method code(s): b21, h6: fda results code(s): c21, h6: fda conclusion code(s): d16; d1: heartware ventricular assist system ¿ battery, d4: model #: 1650 / catalog #: 1650 / expiration date: 31-jul-2023 / serial or lot#: (b)(6) udi #: (b)(4), d9: no, h3: no, device evaluation anticipated, but not yet begun, h4: mfg date: 18-jul-2022, h5: no, h6: patient ime code(s): e2403, h6: imf code(s): f26, h6: img code(s): g02002, h6: fda device code(s): a0705, h6: fda method code(s): b21, h6: fda results code(s): c21, h6: fda conclusion code(s): d16; d1: heartware ventricular assist system ¿ battery, d4: model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2023 / serial or lot#: (b)(6), udi #: (b)(4), d9: no, h3: no, device evaluation anticipated, but not yet begun, h4: mfg date: 29-sep-2022, h5: no, h6: patient ime code(s): e2403, h6: imf code(s): f26, h6: img code(s): g02002, h6: fda device code(s): a0705, h6: fda method code(s): b21, h6: fda results code(s): c21, h6: fda conclusion code(s): d16.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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A supplemental report is being submitted for device analysis.Product event summary: wo (2) controllers (b)(6) and nine (9) batteries (b)(6) were returned for evaluation.Four (4) batteries (b)(6) were not returned for evaluation.No performance allegations were made against (b)(6).A review of the manufacturing documentation confirmed that (b)(6) met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned devices revealed that the batteries passed visual inspection and functional testing.Visual inspection of the returned controllers revealed contamination within all the power ports.Supplemental testing on (b)(6) revealed that the gold-plating of both power port pins were worn, exposing the base metal.Additionally, supplemental testing also revealed contamination within the pins of both power ports, it was detected that a pin on power port one (1) was slightly bent and it was observed a large spring gap between the controller receptacle spring and trough caused by a damaged receptacles within port one (1).Visual inspection of (b)(6) also revealed contamination within the pump connector.Internal visual inspection of the returned devices revealed no abnormalities.Of note, log file analysis indicated that (b)(6) was not in use with the pump and was likely the patient's backup controller.Log file analysis of (b)(6) revealed three (3) controller power up events with associated motor starts, two (2) were logged on 28/may/2023 at 4:07:54 and 4:08:40 and one (1) logged on 06/jun/2023 at 18:47:41.No anomalies were observed leading to the loss of power.The controller was without power for 11 seconds, approximately 43 seconds, and 9 seconds respectively.Following the second controller power up event on 28/may/2023, the controller power down time was recorded with an invalid time stamp of 4:05:08.This is an additional finding not related to the reported event.The potential exists for the timestamp on a power down event written to the log files to be inaccurate.This is due to the timing of operations by the software used to calculate the power down time.The most likely root cause of the observed invalid timestamp event can be attributed to the software design for calculating the power down time.Log file analysis revealed that the controller in use during the reported event, (b)(6), contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Log file analysis revealed several instances involving (b)(6) and a power adapter where the relative state of charge (rsoc) value was logged between 101-201, which is indicative of a communication error.A communication error will trigger a power disconnect alarm if the other power source is a battery with an rsoc greater than 25%.In addition, three (3) critical battery alarms were logged involving (b)(6) due to a communication error.Analysis of the data log file revealed premature power switching events that were due to momentary disconnections involving (b)(6) and a premature power switching event that was due to a communication error involving (b)(6) within the analyzed period.Analysis of the data log file also revealed several momentary disconnections that did not lead to premature power switching events involving (b)(6) and a power adapter.Momentary disconnections will result in an audible tone or 'beep'.The momentary disconnections may explain the reported "battery fault alarm" event.The batteries were lubricated prior to release.As a result, the reported events, except for the reported battery not holding charge, were confirmed.The most likely root cause of the observed power port and pump connector contamination can be attributed to handling of the device.The most likely root cause of the premature power switching events can be attributed to momentary disconnections and communication errors.The most likely root cause of the critical battery alarms and reported power disconnect alarms can be attributed to communication errors.Possible root causes of the communication errors can be attributed to the controller not receiving responses from the battery, the packet error checking method detecting bit errors, and/or momentary disconnections on the communication pins of the controller.The most likely root cause of the reported ¿battery fault alarms¿ can be attributed to momentary disconnections.Capa pr00574181 is investigating momentary disconnections.The most likely root cause of the bent pin within power port one (1) is attributed to misalignment during connection attempts between the metal receptacles on the controller and the plastic connector plugs in the battery and/or adapter cables.The misalignment results in wear on the connector plugs that can lead to contact between the connector plug and socket pins from the controller.The socket pins may not withstand applied forces from subsequent misaligned connections, causing the pins to bend.A possible root cause of the losses of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa pr00551638 is investigating controller losses of power.Additional products: d4: serial or lot#: (b)(6) d9: yes, return date: 13-jun-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 15-jun-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 13-jun-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 13-jun-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 13-jun-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 15-jun-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 15-jun-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 15-jun-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 15-jun-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D1: heartware ventricular assist system ¿controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-may-2023 / serial or lot#: (b)(6) udi #: (b)(4) d9: yes, return date: 15-jun-2023 h3: yes dev rtn to mfr? yes h4: mfg date: 13-may-2022 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.D1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 30-jun-2023 / serial or lot#: (b)(6) udi #: (b)(4) d9: no h3: yes h4: mfg date: 29-jun-2022 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.D1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 30-sep-2023 / serial or lot#: (b)(6) udi #: (b)(4) d9: no h3: yes h4: mfg date: 30-sep-2022 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.D1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 30-jun-2023 / serial or lot#: (b)(6) udi #: (b)(4) d9: no h3: yes h4: mfg date: 27-jun-2022 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.D1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 30-jun-2023 / serial or lot#: (b)(6) udi #: (b)(4) d9: no h3: yes h4: mfg date: 30-jun-2022 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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