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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY; VENTRICULAR (ASSISST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY; VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1650
Device Problems Battery Problem (2885); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  malfunction  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.Continuation of d10: ddpb3d1 icd implant date: (b)(6) 2021.5076-52 <(>&<)> 694765 leads implant date: (b)(6) 2011 additional products: d1: heartware ventricular assist system ¿ battery d4: model#: 1650 / catalog#: 1650 / expiration date: 30-sep-2024 / serial#: (b)(6).Udi#: (b)(4).D9: no h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? no h4: mfg date: 15-sep-2023 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.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.
 
Event Description
It was reported that a battery exhibited a power disconnect alarm observed in log files.  it was also reported that the patient brought a battery into the clinic that had the word "bad" written on it with a sharpie. the batteries will be returned. no patient complications have been reported as a result of this event.
 
Manufacturer Narrative
A supplemental report is being submitted for device analysis.Product event summary: two (2) batteries ((b)(6)) were returned for evaluation.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.Internal visual inspection of the batteries revealed no anomalies.Of note, the word "bad" was written on the battery housing of (b)(6).However, this did not impact the legibility of the battery labeling or damage the housing.Log file analysis revealed that the controller in use during the analyzed period ((b)(6)) contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Review of the alarm log file did not reveal any power disconnect alarms within the analyzed period; however, review of the data log file revealed two (2) instances involving (b)(6) where the battery¿s relative state of charge (rsoc) value was logged between 101-201, which is indicative of a communication error.As a result, the reported power disconnect alarm event was confirmed for (b)(6).The reported event associated with (b)(6) could not be confirmed.(b)(6) had been lubricated prior to release.Possible root causes of the communication errors, and resulting power disconnect alarms, can be attributed to momentary disconnections on the communication pins of the controller, the controller not receiving responses from the batteries, and/or due to the packet error checking method detecting bit errors.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
It was further reported that the controller and multiple batteries exhibited power switching.The patient described multiple single beeps when not reconnecting power sources (allegedly on the same side), and when moving around.A no power alarm occurred although connected to power sources.
 
Manufacturer Narrative
A supplemental report is being submitted for additional information was received.Additional products: d1: heartware ventricular assist system ¿ controller d4: model #: 1420 / catalog #: 1420 / expiration date: 30-sept-2019 / serial (b)(6) udi (b)(4) d9: no h3: no h4: mfg date: 07-sept-2018 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.Investigation of this event is pending and a supplemental report will be sent upon its completion.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Manufacturer Narrative
A supplemental report is being submitted for device evaluation.Product event summary: one (1) controller (b)(6) and two (2) batteries (b)(6) were returned for evaluation.One (1) battery (b)(6) was not returned for evaluation.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 batteries revealed that the devices passed visual inspection and functional testing.Internal visual inspection of the batteries revealed no anomalies.Of note, the word "bad" was written on the battery housing of (b)(6).However, this did not impact the legibility of the battery labeling or damage the housing.Failure analysis of the returned controller (b)(6) revealed that the device passed functional testing.Visual inspection revealed contamination within both power ports.Supplemental testing 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; no damage was observed with the controller receptacles' springs and troughs.Additionally, supplemental testing also revealed contamination within the pins.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 disconnection within each 15 minute interval.Analysis of the data log files revealed several premature power switching events due to momentary disconnections involving (b)(6) , as well as momentary disconnections that did not lead to power switching involving (b)(6) 6.Momentary disconnections will result in an audible tone or ¿beep¿.Additionally, analysis of the data log files revealed several premature power switching events due to communication errors involving (b)(6).Log file analysis also revealed two (2) controller power-up and associated pump start events logged on (b)(6) 2024 at 15:47:22 and on (b)(6) 2024 at 18:31:13.Several momentary disconnections were recorded leading up to the losses of power.The controller was without power for eight (8) seconds and nine (9) seconds, respectively.Review of the alarm log file did not reveal any power disconnect alarms within the analyzed period; however, review of the data log file revealed two (2) instances involving (b)(6) where the battery¿s 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 power adapter or a battery with an rsoc greater than 25%.Analysis of the alarm log file also revealed a critical battery alarm was logged on (b)(6) 2024 at 15:25:46 involving (b)(6) due to the battery depleting below 10% rsoc.The alarm log file also revealed that a vad disconnect alarm was logged on (b)(6) 2024 at 10:54:22, indicating physical disconnection of the driveline from the controller.As a result, the reported power switching and loss of power events were confirmed.However, the reported power disconnect event involving (b)(6) could not be confirmed.The associated batteries were lubricated prior to release.Possible root causes of the communication errors, and resulting power disconnect alarms, can be attributed to momentary disconnections on the communication pins of the controller, the controller not receiving responses from the batteries, and/or due to the packet error checking method detecting bit errors.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.Based on an investigation conducted under capa pr00574181 and the available information, the most likely root cause of the reported power switching event can be attributed to momentary disconnections due to fretting corrosion of the controller-port/power-source pins and/or contamination on the controller receptacle sockets/power source pins.Even though this capa is now closed, (b)(6) and associated batteries fall in scope of this capa.The most likely root cause of the observed contamination within the controller ports event can be attributed to the handling of the device.Additional products: (b)(6) h3: yes d9: yes, return date (b)(6) 2024 (b)(6) h3: yes d9: yes, return date (b)(6) 2024 d1: heartware ventricular assist system ¿ battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2024 / serial or lot#: (b)(6) d9: no h3: yes h4: mfg date: (b)(6) 2023 h5: no 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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
It was further reported that the manufacturer received product performance data.Manufacturer's analysis subsequently revealed an additional battery exhibited a communication error.The battery remains in use.
 
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Brand Name
HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
Type of Device
VENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
gerard torenvliet
8200 coral sea st ne
mounds view, MN 55112
7635269277
MDR Report Key18789350
MDR Text Key336785076
Report Number3007042319-2024-01088
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707009942
UDI-Public00888707009942
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 08/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/30/2023
Device Model Number1650
Device Catalogue Number1650
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/16/2024
Initial Date FDA Received02/27/2024
Supplement Dates Manufacturer Received05/10/2024
05/13/2024
08/08/2024
Supplement Dates FDA Received05/16/2024
05/23/2024
08/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
1103 VAD
Patient Age48 YR
Patient SexMale
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