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

Model Number	102515
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event, of the battery terminals damaged, was confirmed when the returned pack was evaluated.The battery terminals on the returned pack were damaged due to fluid ingress.Three out of the seven battery terminals were damaged with discoloration markings and missing plating.The customer reported that one terminal had metal (plating) missing.Despite the damage to the pack terminals, the pack was operational and had typical battery capacity when checked.The pack had 2 usage cycles on it.The pack was accepted for charge in a heartmate charger.The pack was able to power a heartmate lvad when operationally checked.The pack fuel gauge parameters were typical of an in-use pack.The pack capacity was checked at the maximum load with an electronic load-based test system; the run-time capacity was in-line with typical battery pack capacities and exceeded the design specification.Maintenance of heartmate clips and batteries periodically and prior to use is specified the heartmate 3 lvas instructions for use (ifu) (p.8-8 - caring for heartmate batteries and clips) and the heartmate 3 lvas patient handbook (p.248 - caring for heartmate batteries and clips).These documents also address keeping the batteries clean and dry to prevent damage.Warnings and cautions about getting the heartmate 3 lvas components wet are documented in the heartmate 3 lvas patient handbook ( p.140 caring for the driveline; p.145 showering).The pack was received into stock on (b)(6) 2021.The pack was sent to the customer on (b)(6) 2021.The manufacturing date on the pack label was jul 29, 2021; the pack expiration date would be jul 29, 2024.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the equipment manger checked the equipment and noticed a piece of the metal on one of the battery's terminals was missing.

• Brand Name: HEARTMATE 14 VOLT LITHIUM ION BATTERY
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13306652
• Report Number: 2916596-2022-00401
• Device Sequence Number: 14370683
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: 813024011255
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2024
• Device Model Number: 102515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 68 KG