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

Model Number	2365
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed. .
Event or Problem Description
It was reported that traces of battery acid had been found on the contact pins of slot 4 in the universal battery charger.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of corrosion on the 14v battery contacts was not confirmed.The 14v battery was not returned.The provided information stated that a foreign substance was found in slot 4 of the universal battery charger (ubc) and has been presumed to come from the 14v battery.The ubc was evaluated and the ingress led to the presence of corrosion on the pocket cable assembly.There were no pictures or additional documents of the battery provided.A root cause for the reported event cannot be conclusively determined through this analysis.Device history records could not be reviewed due to the serial number of the 14v battery being unavailable.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.The ubc instructions for use (ifu) explains under the responding to advisory messages how to troubleshoot any errors or alarms.It states under the precautions section: "the metal contacts inside the ubc pockets should be kept clean and dry.Do not expose contacts to water, moisture, dirt, etc.No further information was provided.The manufacturer is closing the file on this event.

• 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: 13721507
• Report Number: 2916596-2022-01579
• Device Sequence Number: 4494121
• Product Code: DSQ
• UDI-Device Identifier: 00813024010876
• UDI-Public: 00813024010876
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: Other
• Device Model Number: 2365
• Device Catalogue Number: 2365
• Was Device Available for Evaluation?: No
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown