HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
Report
- Report Number
- 2916596-2024-02808
- Event Type
- Malfunction
- Date Received
- May 15, 2024
- Date of Event
- April 24, 2024
- Report Date
- September 4, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024011187
- PMA / PMN Number
- P060040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE SUBMITTED LOG FILE REVEALED MINOR ELEVATIONS IN PUMP POWER AND FLOW. ALTHOUGH A SPECIFIC CAUSE FOR THESE FINDINGS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE ACCOUNT SUSPECTED THE EVENTS HAD A CLINICAL CAUSE. THE SUBMITTED LOG FILE CAPTURED MINOR, TRANSIENT ELEVATIONS IN PUMP POWER AND FLOW THROUGHOUT THE FILE. OF NOTE, THESE ELEVATIONS WERE ASSOCIATED WITH PI EVENTS. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED THROUGHOUT THE DURATION OF THE FILE. THE PATIENT REMAINS ONGOING ON HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) REV. B IS CURRENTLY AVAILABLE. SECTION 1 "INTRODUCTION¿ ADDRESSES PUMP PARAMETERS INCLUDING PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX (PI). IN REFERENCE TO POWER, THIS SECTION EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. SECTION 6 "PATIENT CARE AND MANAGEMENT" EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING, EXPLAINS THAT PUMP FLOW IS ESTIMATED FROM PUMP POWER, AND ADDRESSES ASSESSING PUMP FLOW. SECTION 4 EXPLAINS THAT IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED WILL AUTOMATICALLY REDUCE TO THE LOW SPEED LIMIT AND SLOWLY RAMP BACK UP TO THE FIXED SPEED SETPOINT. PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHERE THERE IS A SUDDEN AND SUBSTANTIAL CHANGE IN PI. SOME REASONS FOR PI CHANGES INCLUDE SUDDEN CHANGES IN THE PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE. SECTION E1: REPORTER ADDRESS LINE 1: (B)(6). SECTION E1: REPORTER POSTAL OFFICE OR ZIP CODE: (B)(6).
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
IT WAS REPORTED THAT THE CLINICIANS COMPLAINED THAT THE PUMP PARAMETERS OF THE PATIENT WERE NOT STABLE WHEN CLINICIANS CHECKED THE DATA LOG FILE REVIEW WAS REQUESTED, AND THERE WERE NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. IT WAS ADDITIONALLY STATED THAT WHEN THE VENTRICULAR ASSIST DEVICE (VAD) CHECK WAS CARRIED OUT IN THE OUTPATIENT DEPARTMENT, THE CHANGE IN THE MONITOR DISPLAY VALUES (PUMP POWER, PULSATILITY INDEX, AND FLOW) WERE SEVERE AND UNSTABLE, SO THE CLINICIANS WERE CONTACTED FOR AN ANALYSIS. ON (B)(6) 2024, THE RESPONSE WAS COMPLETED WITHOUT ANY PRODUCT ABNORMALITIES. THE PATIENT REPORTEDLY DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
IT WAS ADDITIONALLY REPORTED THAT THE PARAMETERS WERE SEVERE AND UNSTABLE BECAUSE THE FLOW FLUCTUATED A LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 489074 | HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 105306 | 00813024011187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male |