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

Model Number 1103

Device Problems Increase in Suction (1604); Pumping Problem (3016)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 05/24/2020

Event Type  Injury  

Manufacturer Narrative

### this regulatory report is being submitted as part of a retrospective review and remediation per d00595825 due to an fda audit observation.Product event summary: the pump (hw30286) and two (2) controllers (con313890, con305421), and six (6) batteries (bat583068, bat582900, bat556848, bat556812, bat588510, bat586827) were not returned for evaluation.Log file analysis associated with con313890 revealed four (4) controller power up events were logged between 16-apr-2020 and 24-may-2020.The controller can only store a maximum of 30 days of data.After reaching the limit, the controller initiates a first-in first-out method whereby the oldest data point is deleted to allow the newest data point to be recorded.As a result, data logs covering the power up events were not available.Log file analysis associated with con313890 also revealed 86 critical battery alarms and 13 controller fault alarms were logged between 24-may-2020 and 21-jun-2020.The critical battery alarms involving bat582900, bat588510, bat556812, bat583068, bat586827, and bat556848 were logged due to the batteries depleting below 10% relative state of charge (rsoc).A controller fault alarm will occur if a battery is approaching 0% rsoc.Review of the event log file associated with con313890 revealed also a controller power up event on (b)(6) 2020 at 23:49:19.The data point recorded before the power up event revealed that bat588510 was connected to power port one (1) and bat582900 was connected to power port two (2); both batteries were allowed to deplete completely, resulting in a loss of power to the controller.Additionally, log files associated with con313890 revealed a sudden decrease in power consumption and estimated flows beginning on (b)(6) 2020 leading to parameters below the normal operating range and one (1) suction alarm was logged on (b)(6) 2020.Two vad disconnect alarms associated with con313890 were logged on (b)(6) 2020 since 04:34:14 indicating a physical disconnection of the driveline from the controller, likely due to troubleshooting during the reported controller exchange.Log file analysis associated with con305421 revealed a controller power up event logged on 03-jul-2020 at 05:57:23.Additionally, a vad disconnect alarm was then logged at 05:57:31, likely indicating that the driveline was not connected to the controller.Review of the data log file associated with con305421 revealed that the controller was not in use prior to the controller power up event; the first data point was logged at 05:58:00 on 03-jul-2020, indicating that the power up event and vad disconnect alarm occurred during a controller exchange.Log file analysis associated with con305421 also revealed 95 low flow alarms were logged since 03-jul-2020.As a result, the reported critical battery alarms, controller fault alarms, low flow alarms, suction alarm, and controller power up event associated with a controller exchange were confirmed.Information provided by the site indicated, in addition to the low flow and suction event, the patient presented to the hospital with ventricular assist device (vad) low flow alarms.It was also repor ted that the patient experienced worsening heart failure and was intubated.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the low flow and suction event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.Based on the available information, a possible root cause of the reported critical battery alarms and controller fault alarms can be attributed, but not limited, to the batteries depleting below 10%.A possible root cause of the observed losses of power involving con313890 can be attributed to a disconnection of both power sources, to an intermittent disconnection on one or both power sources, and or the batteries depleting below 10%.Capa pr00551638 is investigating controller losses of power.Based on the available information, the most likely root case of the controller power up event involving con305421 may be attributed to a controller exchange.Per the instructions for use, worsening heart failure is a known potential complication associated with the implantation of a vad.There was no evidence that the patient had a history of worsening heart failure.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Additional products: heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 31-oct-2018 / serial #: (b)(4) udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: yes.Mfg date: 31-oct-2017 labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿battery.Model #: 1650 / catalog #: 1650 / expiration date: 31-jul-2018 / serial #: (b)(4).Udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: yes.Mfg date: 31-jul-2017 labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿battery.Model #: 1650 / catalog #: 1650 / expiration date: 31-jul-2018 / serial #: (b)(4).Udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: yes.Device manufacture date: mfg date: 31-jul-2017.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿battery.Model #: 1650 / catalog #: 1650 / expiration date: 30-jun-2018 / serial #: (b)(4).Udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: yes.Mfg date: 30-jun-2017.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-jun-2018 / serial #: bat556812 udi #: 00888707000376 d9: no device evaluated by mfr yes h4: mfg date: 30-jun-2017 labeled for single useno (b)(4).Heartware ventricular assist system ¿battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-nov-2018 / serial #: bat588510 udi #: 00888707000369 d9: no device evaluated by mfr yes h4: mfg date: 06-nov-2017 labeled for single useno.(b)(4).Heartware ventricular assist system ¿battery d4: model #: 1650 / catalog #: 1650 / expiration date: 31-oct-2018 / serial #: bat586827 udi #: 00888707000369 d9: no device evaluated by mfr yes h4: mfg date: 31-oct-2017 labeled for single useno (b)(4).Heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-may-2018 / serial #: con305421 udi #: 00888707000420 d9: no device evaluated by mfr yes h4: mfg date: 31-may-2017 labeled for single useno.(b)(4).If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there were multiple appropriate critical battery alarms and controller fault alarms.The patient had a history of letting their batteries run low and it appeared that the controller fault alarms were due to the low external battery power and resolved with changing the power sources.Almost six weeks later, the patient presented to the hospital with ventricular assist device (vad) low flow alarms and the cause of the low flows was unknown.Review of logfiles revealed a suction alarm and decrease in average power and pulsatility beginning four days ago.It was also reported that the patient experienced worsening heart failure and was intubated.During a controller exchange, the backup controller was off for more than an hour.The vad, back up controller, and batteries remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14604178
• MDR Text Key: 293376759
• Report Number: 3007042319-2022-05330
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male