MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE UNIVERSAL BATTERY CHARGER, EU; VENTRICULAR (ASSIST) BYPASS

Model Number L103869

Device Problems Mechanical Problem (1384); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2022

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

It was reported that the universal battery charger was damaged after exposure to water and showed a s0003 error on slot.There was evidence of burn marks on the motherboard noted.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported fluid ingress in the universal battery charger (ubc) was confirmed via product testing.The heartmate universal battery charger (serial #: (b)(6)) was at the abbott european distribution center (edc) and no log files were submitted for review.The system was able to boot up as intended.The system gave a s0003 charging error on slot 4.The ubc was opened and marks from short circuiting from fluid ingress were observed on the power supply pcb.The pcb was replaced, and the unit was able to pass all stages of testing.The unit was placed in the abbott rental pool after testing.The root cause of the reported event was unable to be determined in this analysis.The device history records were reviewed and the records revealed the heartmate iii system controller (serial#: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.Heartmate iii instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 ¿ ¿alarms and troubleshooting¿ explains how to properly interpret and troubleshoot all alarms.Heartmate iii instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate iii patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE UNIVERSAL BATTERY CHARGER, EU
• Type of Device: VENTRICULAR (ASSIST) 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: 14655987
• MDR Text Key: 295435912
• Report Number: 2916596-2022-11526
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L103869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female