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A supplemental report is being submitted as additional information was received in the event: updated section b5 additional products: d1: heartware ventricular assist system ¿controller 2.0 d4: model #: 1420/ catalog #: 1420/ expiration date: 2020-11-30/ serial or lot#: con408868 udi #: (b)(4) d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 2019-11-18 h5: no h6: patient ime code(s): e2403 h6: imf code(s): f26 h6: img code(s): g04035 h6: fda device code(s): a0708 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 investigation of this event is pending and a supplemental report will be sent upon its completion.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 evaluation and investigation completion.Product event summary: the controller ((b)(6)) was returned for evaluation and controller ((b)(6)) was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.Failure analysis of the returned controller revealed that the device passed functional testing.Visual inspection revealed contamination within both power ports, the serial port, and the pump connector.The serial port and pump connector contamination are additional findings not related to the reported event.Additionally, visual inspection under 10x magnification revealed hairline cracks at the corners of the controller housing near the serial port and pump connector.An internal inspection did not reveal evidence of fluid ingress.The observed hairline crack is not related to the reported event.Based on an investigation conducted under capa pr00517125, the root cause of hairline cracks found at the corners of the controller was determined to be due to environmental stress cracking from a combination of chemical incompatibility and mechanical stresses.The chemical incompatibility is attributed to mineral oil leaching from the controller¿s housing gasket and migrating to the controller housing.The mechanical stresses are caused by the ultrasonic welding of inserts located within the corners¿ thinner wall.Supplemental testing was performed on the controller and the test results revealed that the gold-plating of the pins were worn, exposing the base metal.The exposure of the base metal is susceptible to the effects of corrosion.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.Analysis of the data log file revealed several premature power switching events that were due to momentary disconnections between the controller and a power adapter.Analysis of the data log files revealed several momentary disconnections that did not lead to premature power switching events between the controller and batteries.Momentary disconnections will result in an audible tone or 'beep'.Analysis of the event log file revealed five controller power-up events with associated motor start events logged on (b)(6) 2021 at 08:42:27, 11:30:14, 11:30:40, 11:31:03, and 11:32:06.The controller was without power for seven seconds, 20 seconds, 17 seconds, 19 seconds, and 59 seconds, respectively.No anomalies were recorded leading up to the losses of power.As a result, the reported loss of power, premature power switching, and beeping events involving (b)(6) were confirmed.Log file analysis pertaining to (b)(6) revealed a controller power-up with an associated motor start event logged on (b)(6) 2021 at 11:05:22.Analysis of the event log file revealed that, prior to the first power up event, the controller last had power on (b)(6) 2021.Review of the data log file revealed that the controller was not in use prior to the controller power up event; the first data point was logged at 11:05:55 on (b)(6) 2021, indicating that the power up events occurred during a controller exchange.As a result, the reported controller power up event involving (b)(6) was confirmed.The associated power sources were lubricated prior to release.Lubrication servicing could not be confirmed for the power adapter since the serial number is unknown.Based on the available information, the controller power up event involving (b)(6) was most likely due to a controller exchange.The most likely root cause of the observed contamination with the controller ports can be attributed to handling of the device.The most likely root cause of the reported premature power switching and beeping events can be attributed to momentary disconnections due to contamination within the power ports and/or due to temporary corrosion of the controller-port/power-source pins.Capa pr00389403 investigated momenta ry disconnections prior to lubrication servicing.Even though this capa is closed, (b)(6) fall within the bounds of this capa.A possible root cause of the losses of power involving (b)(6) can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Additional products: d4: serial #:(b)(6).H3: yes.H6: fda method code(s): b15,b17.H6: fda results code(s): c19 h6: fda conclusion code(s): d14 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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