BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9468676 · Received December 13, 2019

    Report

    Report Number
    2916596-2019-05654
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 25, 2019
    Report Date
    February 27, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4, H4: ADDITIONAL INFORMATION. SECTION H5: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A NO EXTERNAL POWER ALARM OBSERVED IN THE PROVIDED LOG FILE WAS CONFIRMED. THE LOG FILE CONTAINED EVENTS RECORDED FROM (B)(6) TO (B)(6) 2019 WHERE A NO EXTERNAL POWER ALARM WAS RECORDED ON NOVEMBER 24. THE ASSOCIATED VOLTAGE LEVELS INDICATED THAT THE EVENTS OCCURRED WHILE THE SYSTEM CONTROLLER WAS CONNECTED TO A MPU AND THE POWER TO THE MPU WAS LOST. THE PUMP SUPPORT WAS NOT AFFECTED AND THE SYSTEM WAS SUPPORTED BY THE BACKUP BATTERY DURING THE EVENT. A SPECIFIC ROOT CAUSE FOR THE NO EXTERNAL POWER EVENT WAS NOT ABLE TO BE DETERMINED. THE (B)(6) WAS NOT RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. HEARTMATE II LVAS IFU (SECTION 7), HEARTMATE II PATIENT HANDBOOK, UNDER ALARMS AND TROUBLESHOOTING, DESCRIBES ALL ALARMS (VISUAL AND AUDIBLE) AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR. THIS INCLUDES THE NO EXTERNAL POWER ALARM. TO RESOLVE ALARM: 1. IMMEDIATELY CONNECT THE SYSTEM CONTROLLER POWER CABLES TO A WORKING POWER SOURCE (FUNCTIONING POWER MODULE OR TWO FULLY-CHARGED HEARTMATE 14 VOLT LITHIUM-ION BATTERIES). 2. CALL YOUR HOSPITAL CONTACT IMMEDIATELY IF CONNECTING TO POWER DOES NOT RESOLVE THE ALARM. HEARTMATE II LVAS IFU AND HEARTMATE II PATIENT HANDBOOK: BOTH OF WHICH CAUTION 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P060040; P160054. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER REQUESTED A LOG FILE REVIEW. THE MANUFACTURER TECHNICAL SERVICES REVIEWED THE LOG FILES AND OBSERVED MULTIPLE NO EXTERNAL POWER ALARMS WHILE THE PATIENT WAS ON THE MOBILE POWER UNIT (MPU). THIS WAS CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THIS MAY BE DUE TO THE POWER CORD COMING LOOSE FROM THE WALL OUTLET OR THE HOUSE LOSING POWER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264202 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR