MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA

Model Number 107754

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device - 3 years, 1 month.The patient remains ongoing with the lvad device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2015.It was reported that the patient had multiple loss of external power which patient denied hearing.It was reported that the devices were replaced in last few months.Manufacturer's technical service review noted 3 no external power events on (b)(6) 2019 4:18 am, (b)(6) 2019 8:49 am, and (b)(6) 2019 10:37 am due to the mpu ac power cable coming loose at the ac wall outlet due to possible patient error.It was reported that the patient have a locking version of the mpu ac power cable.The log file also displayed 1 transient backup battery fault alarm on (b)(6) 2019 10:37am that appeared to have resolved.Additional information from the account was received on (b)(6) 2019.It was reported that the reported alarms were not resolved, the patient denies these alarms, which was most likely patient negligence.No device was exchanged and the mpu sn# was (b)(4) was provided.However, the low flow alarms were resolved.It was communicated that the reported events were due to likely patient condition and due to patient negligence since patient continues to have these alarms and denies them.No further diagnostic tests were performed.The patient is currently stable and will continue to monitor.No other symptoms were reported recently.No further information was provided.

Manufacturer Narrative

Approximate age of device - 8 months.Section h4, h8: additional information.Manufacturer's investigation conclusion: the reported event of no external power alarms was confirmed via the submitted log file.The submitted log file contained 240 events spanning approximately 29.5 days 09jan2019 ¿ 07feb2019 per the timestamp).The no external power alarm was active several times throughout the log file due to momentary losses of power on both the black and white power cables.The no external power alarms only occurred while connected to the mpu.The backup battery supplied power to the system without issue when external power was lost.The pump maintained a speed above the low speed limit throughout the log file.The returned mpu was evaluated by technical services under work order (b)(4).A new locking ac power cord was connected to the returned mpu, as the mpu was returned without an ac power cord.The mpu was connected to a mock circulatory loop for several days without issue; no alarms were produced.Cosmetic damage to the patient cable was observed.The damaged patient cable was replaced with a new patient cable.A full functional checkout was then performed and the unit passed all tests.The unit was returned to the customer site.The mpu patient cable was further evaluated by product performance engineering (ppe).Several kinks were observed on the patient cable.The resistances of the mpu patient cable were measured and no issues were observed.The mpu patient cable was connected to a test mpu, system controller, and mock circulatory loop and no issues were observed.The patient cable was manipulated by hand with no alarms active.The underlying wires were inspected and several of the wires were found to be kinked; however, no conductor breakdown was observed.The mpu was returned without an ac power cord, however it was reported that the patient has the locking version of the mpu ac power cord.Additional information provided stated that the patient is currently using a new mpu with no issues reported.A review of the patient history revealed that the patient has experienced additional no external power and low voltage alarms while connected to the mpu.The patient has previously exchanged the mpu, and damage to the mpu patient cable has previously been observed.The root cause of the no external power alarms could not be conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Type of Device: MOBILE POWER UNIT
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8356328
• MDR Text Key: 137947615
• Report Number: 2916596-2019-00704
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• Combination Product (y/n): N
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98