BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 12192077 · Received July 19, 2021

    Report

    Report Number
    2916596-2021-03875
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    July 7, 2021
    Report Date
    October 29, 2021
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW ALARMS WHEN THE PATIENT WAS PLACED ON THE MOBILE POWER UNIT (MPU). ALTHOUGH A SPECIFIC CAUSE FOR THESE FINDINGS COULD NOT BE CONCLUSIVELY DETERMINED DURING THIS EVALUATION, THE ABNORMAL PUMP OPERATION CAPTURED IN THE SUBMITTED LOG FILE APPEARED TO BE CONSISTENT WITH POTENTIAL DRIVELINE WIRE COMPROMISE. THE SUBMITTED LOG FILE CAPTURED PUMP STOPS AT 23:50:01 ON (B)(6) 2021, 00:05:30 ON (B)(6) 2021, 00:27:17 ON (B)(6) 2021, AND 00:28:12 ON (B)(6) 2021 WHILE THE PATIENT WAS CONNECTED TO THE MOBILE POWER UNIT. TRANSIENT LOW SPEED ADVISORIES, LOW SPEED HAZARDS, AND LOW FLOW HAZARDS WERE CAPTURED DURING THIS TIME AS WELL. NO OTHER ATYPICAL EVENTS OR ALARMS WERE CAPTURED. POWER ELEVATIONS GREATER THAN 12 WATTS WERE ALSO CAPTURED AT THIS TIME, CORRESPONDING WITH THE PUMP RAMPING BACK UP TO SPEED. THE LOW SPEED AND PUMP STOP EVENTS IN THE LOG FILE APPEAR CONSISTENT WITH A COMPROMISED WIRE WITHIN THE PATIENT¿S DRIVELINE; HOWEVER, A SPECIFIC CAUSE FOR THE EVENTS CANNOT BE DETERMINED THROUGH THE EVALUATION OF THE RETURNED DRIVELINE. THE PATIENT REMAINS ONGOING ON HEARTMATE (HM) II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) AND NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HM II LVAS IFU AND PATIENT HANDBOOK PROVIDE INFORMATION REGARDING HOW TO CARE FOR THE DRIVELINE AND ADDRESS DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE. THESE DOCUMENTS OUTLINE INDICATIONS OF DRIVELINE WIRE DAMAGE AS WELL AS HOW TO RESPOND TO SUCH EVENTS, AND FURTHER EXPLAIN THAT ALL HEARTMATE II LVAS DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT ON LENGTH OF USE AND MOVEMENT/FLEXING OVER TIME. ADDITIONALLY, THE IFU 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. THIS DOCUMENT ALSO DESCRIBES HOW PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. FURTHERMORE, THESE DOCUMENTS ADDRESS ALL HAZARD AND ADVISORY ALARM, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. 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 LVAS IFU, REV. H AND THE HEARTMATE II PATIENT HANDBOOK, REV. G, ARE CURRENTLY AVAILABLE. THE IFU CONTAINS INFORMATION REGARDING PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX (PI). THE IFU 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. THIS DOCUMENT ALSO DESCRIBES HOW PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. SECTIONS 6 AND 8 OF THE HMII IFU, AS WELL AS SECTIONS 4 AND 6 OF THE HMII PATIENT HANDBOOK, PROVIDE INFORMATION REGARDING HOW THE PATIENT SHOULD CARE FOR THEIR DRIVELINE AND ADDRESSES DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE. THESE SECTIONS STATE THAT DESPITE CARE, ALL HM II DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDING ON DURATION OF USE AND MOVEMENT/FLEXING OVER TIME. ADDITIONALLY, THESE SECTIONS OUTLINE INDICATIONS OF DRIVELINE DAMAGE AS WELL AS THE HOW TO RESPOND TO SUCH EVENTS. FURTHERMORE, SECTION 7 OF THE HMII IFU AND SECTION 5 OF THE HMII PATIENT HANDBOOK ADDRESS ALL HAZARD AND ADVISORY ALARMS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. A SECTION ON ¿HANDLING EMERGENCIES¿ IS ALSO PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2021, THAT THE PATIENT HAD BEEN DIAGNOSED WITH LEUKOCYTOSIS (ELEVATED WHITE BLOOD CELL COUNT) AND THERE WAS CONCERN FOR POSSIBLE INFECTION DURING THIS ADMISSION.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PLACED ON THE MOBILE POWER UNIT ON (B)(6) 2021 AND HAD LOW FLOW ALARMS. FURTHER INTERROGATION SHOWED LOW FLOW ALARMS, LOW SPEED ADVISORIES, AND PUMP OFF EVENTS. THIS APPEARED TO BE AN ISSUE WITH THE DRIVELINE SHORT TO SHIELD. IT WAS RECOMMENDED BY TECHNICAL SERVICES TO KEEP THE PATIENT ON A NON-GROUNDED PATIENT CABLE AND BATTERY POWER. THE SUBMITTED X-RAY IMAGES DO NOT SHOW ANY OBVIOUS AREAS OF SHIELD BREAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086287 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ 106015 6095658 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization