HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
Report
- Report Number
- 2916596-2022-13539
- Event Type
- Injury
- Date Received
- September 19, 2022
- Date of Event
- August 30, 2022
- Report Date
- October 4, 2022
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013181
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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.
MANUFACTURE¿S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED PHOTO CONFIRMED SUPERFICIAL DAMAGE OF THE PUMP CABLE'S OUTER JACKET. A SPECIFIC CAUSE FOR THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES APPEARED TO CAPTURE THE PUMP OPERATING AS INTENDED AT THE SET SPEED; THEREFORE, THE OBSERVED DAMAGE TO THE OUTER JACKET OF THE PUMP CABLE DID NOT APPEAR TO HAVE CONTRIBUTED TO ANY ELECTRICAL ISSUES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 "INTRODUCTION," LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HM3 LVAS. SECTION 5 "SURGICAL PROCEDURES" CAUTIONS THE USER THAT SHARP BENDS, TWISTS, OR KINKS IN THE DRIVELINE MAY MAKE IT MORE SUSCEPTIBLE TO WEAR AND FATIGUE OVER TIME. SECTION 6 "PATIENT CARE AND MANAGEMENT" CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE AND TO NOT TWIST, KINK, OR SHARPLY BEND ANY CABLES, AS IT MAY CAUSE DAMAGE TO THE WIRES INSIDE THAT MAY NOT BE OUTWARDLY VISIBLE AND THAT COULD CAUSE THE PUMP TO STOP. IF KINKING, TWISTING, OR BENDING DOES OCCUR, CAREFULLY UNRAVEL AND STRAIGHTEN. SECTION 6 INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE. SECTION 8 "EQUIPMENT STORAGE AND CARE" STATES, "AS NEEDED, CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP." THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. SECTION 4 "LIVING WITH THE HEARTMATE 3" (UNDER "CARING FOR THE DRIVELINE") INSTRUCTS THE USER: "CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE (CUTS, HOLES, TEARS). CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)" AND "KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE IN WATER OR LIQUID." IN ADDITION, SECTION 5 "ALARMS AND TROUBLESHOOTING¿ CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR A SYNCOPAL EVENT DUE TO ACUTE ANEMIA WITH A HEMOGLOBIN OF 7.1. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AND THE SYNCOPE RESOLVED. GASTROENTEROLOGISTS (GI) CONSULTED AND ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS NEGATIVE.
RELATED MFR# 2916596-2022-14281.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2604173 | HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524 | 6372173 | 00813024013181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Hospitalization| R |