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

Model Number 1650DE

Device Problems Loose or Intermittent Connection (1371); Pumping Stopped (1503); Battery Problem (2885); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

Additional products: brand name: heartware ventricular assist system battery.Model #: 1650de / catalog #: 1650de / expiration date: 30-sep-2018 / serial#: (b)(4), udi #: (b)(4).Device availalble for evaluation: yes, return date: 29-sep-2020, no, device evaluation anticipated, but not yet begun, dev rtn to mfr? yes, mfg date: 30-sep-2017 labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient¿s controller had a loose connection on the left power port.Several batteries were attempted to be attached to the left power port of the controller, but they all were loose.The log files showed multiple unexpected controller power losses associated with ventricular assist device (vad) stops and a power disconnect alarm on one of the batteries.The controller and batteries were suspected for power switching, even though the batteries had been previously lubricated.The controller and all the batteries were exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Additional products: d4: (b)(6).H6: patient ime code(s): e2403.H6: imf code(s): f26.H6: fda method code(s): b01, b15.H6: fda results code(s): c04.H6: fda conclusion code(s): d02.D4: serial # (b)(6).H6: patient ime code(s): e2403.H6: imf code(s): f26.H6: fda method code(s): b01, b15.H6: fda results code(s): c04.H6: fda conclusion code(s): d02.D4: serial # (b)(6).H6: patient ime code(s): e2403.H6: imf code(s): f26.H6: fda method code(s): b01, b15.H6: fda results code(s): c04.H6: fda conclusion code(s): d02.D4: serial # (b)(6).H6: patient ime code(s): e2403.H6: imf code(s): f26.H6: fda method code(s): b01, b15.H6: fda results code(s): c07.H6: fda conclusion code(s): d11.D4: serial # (b)(6).H6: patient ime code(s): e2403.H6: imf code(s): f26.H6: fda method code(s): b01, b15.H6: fda results code(s): c04.H6: fda conclusion code(s): d02.D4: serial # (b)(6).H6: patient ime code(s): e2403.H6: imf code(s): f26.H6: fda method code(s): b01, b15.H6: fda results code(s): c04.H6: fda conclusion code(s): d02.D4: serial # (b)(6).H6: patient ime code(s): e2403.H6: imf code(s): f26.H6: fda method code(s): b01, b15.H6: fda results code(s): c04.H6: fda conclusion code(s): d02.A supplemental report is being submitted for device evaluation.Product event summary: one controller and seven batteries 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 controller revealed that the device passed visual inspection and functional testing.The controller was able to recognize a power source attached on both power ports; all connections were stable with no abnormalities observed.As a result, the reported loose controller power port event was not confirmed.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.Failure analysis of four batteries revealed that the batteries passed functional testing.Visual inspection of four batteries revealed that the batteries had worn damage within the battery connectors.The damage that was observed did not affect the functionality of the devices; the batteries was able to adequately connect to a test controller.Failure analysis of two batteries revealed that the batteries had worn damage within the battery connectors; the batteries were unable to adequately secure a mechanical connection to a test controller.Failure analysis of one battery revealed that the battery had worn damage and a damaged pin within the battery connector.The damaged pin did not allow the battery to charger or provide power to a controller.Additionally, visual inspection revealed contamination within the battery connector.Log files revealed that one battery was not in use within the analyzed period.The observed contamination is an additional finding not related to the reported event and can be attributed to handling of the device.Log file analysis revealed that the controller 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 due to momentary disconnections involving six batteries and several premature power switching events due to communication errors involving two batteries.Log file analysis also revealed multiple controller power up events with associated motor starts were logged between (b)(6) 2020.Several momentary disconnections were recorded prior to the losses of power.The controller was without power for an average of 12 seconds per loss of power.Review of the alarm log file did not reveal any power disconnect alarms.However, review of the data log file revealed multiple instances involving four batteries where the battery's relative state of charge (rsoc) values were logged between 101-201, which is indicative of communication errors.As a result, the reported battery "wear" damage, power switching and losses of power events were confirmed.The reported power disconnect alarms were not confirmed; however, it is likely the observed communication errors are likely related to the reported power disconnect alarm.A power source l ubrication procedure had been performed on the associated batteries in accordance with the requirements under fsca cvg-18-q4-19 on 27/jun/2018.A possible root cause of the losses of power can be attributed to a disconnection of both power sources and/or to an int ermittent disconnection on one or both power sources.The most likely root cause of the reported premature power switching event can be attributed to momentary disconnections due to temporary corrosion of the controller-port/power-source pins, communication errors between the controller and batteries, and/or intermittent disconnections due to a damaged battery connector.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, potentially due a damaged battery connector.Based on the available information, the most likely root cause of the damaged battery connectors can be attributed to handling of the devices and/or wear, likely due to normal disconnection and re-connection between the battery connector and metal power port connectors on the controller.An internal investigation was opened to investigate damage to power sources.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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10613090
• MDR Text Key: 209795485
• Report Number: 3007042319-2020-05923
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000369
• UDI-Public: 00888707000369
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 1650DE
• Device Catalogue Number: 1650DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1103 VAD
• Patient Age: 33 YR