HEARTMATE MOBILE POWER UNIT, NA
Report
- Report Number
- 2916596-2022-00438
- Event Type
- Malfunction
- Date Received
- February 8, 2022
- Date of Event
- January 18, 2022
- Report Date
- April 13, 2022
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024010883
- PMA / PMN Number
- P160054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF NO EXTERNAL POWER ALARMS WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) WAS CONFIRMED. THE MPU (SERIAL NUMBER: (B)(6)) WAS RETURNED TO SERVICE DEPOT FOR EVALUATION AND ISSUE WAS REPRODUCED DURING TESTING. THE ISSUE WAS ISOLATED TO THE MPU PATIENT CABLE. THE PATIENT CABLE WAS REPLACED AND NO FURTHER ISSUES WERE OBSERVED. AFTER REPLACING THE PATIENT CABLE, A FULL FUNCTIONAL CHECKOUT WAS PERFORMED AND THE UNIT PASSED ALL TESTS WITHOUT ISSUE. THE REPLACED PATIENT CABLE WAS FORWARDED TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER ANALYSIS. PPE INSPECTION OF THE RETURNED MPU REVEALED SEVERAL KINKS ALONG THE LENGTH OF THE PATIENT CABLE. THE MPU WAS FUNCTIONALLY TESTED BY PPE WITH A TEST SYSTEM CONTROLLER AND MOCK CIRCULATORY, AND THE NO EXTERNAL POWER ALARM WAS REPRODUCED. THE ALARM DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. FURTHER EVALUATION OF THE PATIENT CABLE REVEALED THAT THE RELATIVE STATE OF CHARGE (RSOC) WIRE WAS SHORTING TO THE CABLE SHIELDING; THIS WOULD RESULT IN THE OBSERVED NO EXTERNAL POWER ALARM. THE OUTER LAYER WAS REMOVED FROM THE PATIENT CABLE IN SEVERAL LOCATIONS IN ORDER TO FIND WHERE THE RSOC WIRE WAS MAKING CONTACT WITH THE SHIELD; HOWEVER, THE EXACT LOCATION OF THE CONTACT COULD NOT BE FOUND. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE MPU, SERIAL NUMBER (B)(6), WAS SHIPPED TO THE CUSTOMER ON 23AUG2021. HEARTMATE 3 PATIENT HANDBOOK (REV. C), UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C), UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE NO EXTERNAL POWER ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. FURTHERMORE, THE SUBSECTION ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿ INFORMS THE USER TO CHECK THE SYSTEM CONTROLLER AND MOBILE POWER UNIT (MPU) POWER CABLES FOR TWISTING, KINKING, OR BENDING WHICH COULD CAUSE DAMAGE TO THE WIRES INSIDE. THIS SECTION INFORMS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE SYSTEM CONTROLLER OR MPU POWER CABLES AND TO CAREFULLY UNRAVEL AND STRAIGHTEN THE CABLES IF THEY BECOME TWISTED, KINKED, OR BENT. HEARTMATE 3 PATIENT HANDBOOK (REV. C) AND HEARTMATE 3 IFU (REV. C) UNDER SECTION 3 ¿POWERING THE SYSTEM¿, SUBSECTION ¿USING THE MOBILE POWER UNIT¿, EXPLAIN HOW TO USE THE MPU, INCLUDING HOW TO CONNECT THE AC POWER CORD TO THE MPU. THIS SECTION ALSO INFORMS THE USER TO TRANSFER FROM THE MPU TO ANOTHER POWER SOURCE IN THE EVENT OF A POWER FAILURE. DO NOT RELY ON THE CONTROLLER¿S BACKUP BATTERY AS A POWER SOURCE AS IT WILL ONLY POWER THE PUMP FOR A LIMITED AMOUNT OF TIME AND THE PUMP WILL STOP. SUBSECTION ¿SWITCHING POWER SOURCES¿ EXPLAINS HOW TO SWITCH FROM THE MPU TO BATTERIES. HEARTMATE 3 PATIENT HANDBOOK (REV. C) SECTION 6 "CARING FOR THE EQUIPMENT" AND HEARTMATE 3 IFU (REV. C) SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ DESCRIBE HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE MPU. HEARTMATE 3 PATIENT HANDBOOK (REV. C) SECTION 10 AND HEARTMATE 3 IFU (REV. C) SECTION F, BOTH ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDE CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING THE MPU. THESE SECTIONS ALSO INFORM THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. HEARTMATE 3 PATIENT HANDBOOK (REV. C) CAUTIONS 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.
IT WAS REPORTED THAT THE PATIENT WAS HAVING NO EXTERNAL POWER ALARMS WHILE CONNECTED TO THEIR MOBILE POWER UNIT (MPU) BUT NOT WHILE ON BATTERY POWER. THE CONNECTION ON THE CORD FROM THE MPU TO THE WALL WAS TIGHT, PER THE PATIENT'S SPOUSE. NO FURTHER ALARMS WOULD BE NOTED WHEN THE PATIENT SWITCHED FROM MPU TO BATTERY POWER. NO BROKEN OR BENT PINS WERE NOTED ON THE END OF THE MPU BATTERY LEAD, ACCORDING TO THE PATIENT'S SPOUSE. THE PATIENT'S SPOUSE WAS NOTED TO CHANGE THE OUTLET THAT THE MPU WAS PLUGGED INTO AND WOULD REGULARLY CHANGE THE DOUBLE A BATTERIES IN THE MPU. WHEN THE PATIENT WOULD PLUG THEIR MPU INTO THE WHITE POWER CABLE AGAIN, THE ALARM WOULD RECUR. BEFORE THE ARRIVAL OF THE PATIENT'S NEW MPU, THE PATIENT WAS INSTRUCTED TO BE USING BATTERY POWER. IT WAS ADDITIONALLY REPORTED ON 3FEB2022 THAT THE PATIENT'S MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD. THE MPU POWER CORD WAS NOT THOUGHT TO HAVE CAME LOOSE AT THE WALL/OUTLET OR BACK OF THE UNIT. NO ENVIRONMENTAL ISSUES WERE REPORTED TO HAVE INTERFERED WITH THE MPU'S POWER.
IT WAS REPORTED THAT THE PATIENT WAS HAVING NO EXTERNAL POWER ALARMS WHILE CONNECTED TO THEIR MOBILE POWER UNIT (MPU) BUT NOT WHILE ON BATTERY POWER. THE CONNECTION ON THE CORD FROM THE MPU TO THE WALL WAS TIGHT, PER THE PATIENT'S SPOUSE. NO FURTHER ALARMS WOULD BE NOTED WHEN THE PATIENT SWITCHED FROM MPU TO BATTERY POWER. NO BROKEN OR BENT PINS WERE NOTED ON THE END OF THE MPU BATTERY LEAD, ACCORDING TO THE PATIENT'S SPOUSE. THE PATIENT'S SPOUSE WAS NOTED TO CHANGE THE OUTLET THAT THE MPU WAS PLUGGED INTO AND WOULD REGULARLY CHANGE THE DOUBLE A BATTERIES IN THE MPU. WHEN THE PATIENT WOULD PLUG THEIR MPU INTO THE WHITE POWER CABLE AGAIN, THE ALARM WOULD RECUR. BEFORE THE ARRIVAL OF THE PATIENT'S NEW MPU, THE PATIENT WAS INSTRUCTED TO BE USING BATTERY POWER. IT WAS ADDITIONALLY REPORTED ON 3FEB2022 THAT THE PATIENT'S MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD. THE MPU POWER CORD WAS NOT THOUGHT TO HAVE CAME LOOSE AT THE WALL/OUTLET OR BACK OF THE UNIT. NO ENVIRONMENTAL ISSUES WERE REPORTED TO HAVE INTERFERED WITH THE MPU'S POWER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1776998 | HEARTMATE MOBILE POWER UNIT, NA | VENTRICULAR (ASSISST) BYPASS | DSQ | THORATEC CORPORATION | 107754 | 00813024010883 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female |