MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 14 VOLT BATTERY CLIP SET; VENTRICULAR (ASSISST) BYPASS

Model Number 2865

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient noticed that the copper tab of new battery clips was not put in correctly as it was hanging out on one side.The patient will return both defective clips and needs replacement.

Event Description

Related manufacturer report number: 2916596-2020-02012.

Manufacturer Narrative

Corrected information: b5, d10, d11, h3.Manufacturer's investigation conclusion: visual examination of the battery clip (lot # 7359626-1) confirmed that the copper tab (contact block terminal) was dislodged and out of place (rail) on one side.Functional testing was performed on the returned battery clip while inserting test 14-volt battery, connecting to a test system controller and hm test lvad pump.Inserting the battery into the clip was done several times with no issue.The battery clips supported the labs test equipment without issue.The battery clip functioned as intended.Although the reported event was confirmed and the clip damage appeared to be mechanical; however, the exact cause for the observed damage cannot be determined.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section h6: correction.

• Brand Name: HEARTMATE 14 VOLT BATTERY CLIP SET
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9863785
• MDR Text Key: 184446418
• Report Number: 2916596-2020-01574
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: 00813024010715
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2865
• Device Catalogue Number: 2865
• Device Lot Number: 7359626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE 14 VOLT BATTERY CLIP SET.
• Patient Age: 65 YR
• Patient Weight: 58