HEARTMATE MOBILE POWER UNIT, UK
Report
- Report Number
- 2916596-2025-03549
- Event Type
- Malfunction
- Date Received
- June 10, 2025
- Date of Event
- May 26, 2025
- Report Date
- August 13, 2025
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024012368
- PMA / PMN Number
- P160054
- Removal / Correction Number
- FA-Q125-HF-2
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
SECTION G4: PMA # CORRECTED. SECTION H6: MEDICAL DEVICE PROBLEM CODE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MOBILE POWER UNIT (MPU) NOT WORKING WAS CONFIRMED. DURING THE EVALUATION AT THE EUROPEAN DISTRIBUTION CENTER (EDC) OF THE RETURNED MPU, SERIAL (B)(6), VISUAL INSPECTION CONFIRMED A NONCONFORMING CAPACITOR ON THE POWER SUPPLY PCBA PER MP, HEARTMATE MOBILE POWER UNIT SERVICE PROCESS. THE UNIT DID NOT POWER ON, AND IT WAS SCRAPPED. ADDITIONAL INFORMATION PROVIDED STATED THAT THERE WERE NO LOG FILES AVAILABLE. THE ROOT CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE A NONCONFORMING CAPACITOR ON THE MPU POWER SUPPLY PCBA, AND A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS INITIATED TO INVESTIGATE THIS ISSUE. INCIDENTAL FINDINGS: LOOSE RUBBER ENCASING. 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 CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. HEARTMATE 3 PATIENT HANDBOOK (REV. B) SECTION 6 ¿CARING FOR THE EQUIPMENT¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. B) SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ EXPLAIN HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE MPU. HEARTMATE 3 PATIENT HANDBOOK (REV. B) SECTION 10 ¿SAFETY CHECKLISTS¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. B) SECTION E ¿SAFETY CHECKLISTS¿ PROVIDE THE USER WITH CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF ALL COMPONENTS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE, INCLUDING THE MPU. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. B) SECTION 8-¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. B) SECTION 6-¿CARING FOR THE EQUIPMENT¿ EXPLAIN HOW TO PROPERLY HANDLE THE EQUIPMENT TO PREVENT DAMAGE. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE DEVICE IS INCLUDED IN THE HEARTMATE MPU CAPACITOR ISSUE FIELD ACTION ISSUED BY ABBOTT ON 28FEB2025. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS FURTHER REPORTED THAT THE MOBILE POWER UNIT (MPU) WAS EQUIPPED WITH A V-LOCK CONNECTOR ON THE AC POWER CORD. THE AC POWER CORD DID NOT COME LOOSE AT THE WALL OUTLET OR FROM THE BACK OF THE UNIT. THERE WERE NOT ANY ENVIRONMENTAL CIRCUMSTANCES THAT WOULD HAVE AFFECTED AC POWER AT THE TIME OF THE EVENT.
IT WAS REPORTED THAT PATIENT WAS TRAVELLING IN MOROCCO WHEN THEIR MOBILE POWER UNIT (MPU) STOPPED WORKING. THIS MPU WAS NOT ALARMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 550164 | HEARTMATE MOBILE POWER UNIT, UK | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 107758UK | 10368274 | 00813024012368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |