BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9524031 · Received December 27, 2019

    Report

    Report Number
    2916596-2019-05933
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    November 30, 2019
    Report Date
    April 29, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE REPORTED EVENT OF A LOW VOLTAGE HAZARD ALARM WHILE CONNECTED TO THE MPU WAS CONFIRMED VIA THE SUBMITTED LOG FILE. THE SUBMITTED LOG FILE CONTAINED APPROXIMATELY 5 DAYS OF DATA ((B)(6) 2019 ¿ (B)(6) 2019 PER THE TIMESTAMP). THE LOG FILE CAPTURED LOW VOLTAGE HAZARD ALARMS ON (B)(6) 2019 FROM 04:34:08 TO 04:34:11 DUE TO A LOSS OF POWER WHILE CONNECTED TO THE MPU. THE SYSTEM CONTROLLER BACKUP BATTERY SUPPLIED POWER TO THE SYSTEM DURING THE LOSS OF EXTERNAL POWER. THE ALARMS WERE RESOLVED WHEN POWER FROM THE MPU WAS RESTORED. THE ALARMS DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. NO OTHER NOTABLE ALARMS WERE ACTIVE IN THE LOG FILE. MULTIPLE ATTEMPTS TO WERE MADE OBTAIN ADDITIONAL EVENT INFORMATION, INCLUDING THE SERIAL NUMBER OF THE MPU, IF THE CAUSE OF THE LOSS OF POWER WAS DETERMINED, AND IF THE MPU HAS A V-LOCK CONNECTOR ON THE AC POWER CORD; HOWEVER, NO RESPONSE WAS RECEIVED. THE HEARTMATE 3 INSTRUCTIONS FOR USE (DOC. #100168999, REV. A) SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (DOC. #10006136, REV. B) SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL ALARMS, INCLUDING LOW VOLTAGE HAZARDS. THE HEARTMATE 3 INSTRUCTIONS FOR USE (DOC. #100168999, REV. A) SECTION 3 ¿ ¿POWERING THE SYSTEM¿ AND HEARTMATE 3 PATIENT HANDBOOK (DOC. #10006136, REV. B) SECTION 3 ¿ ¿POWERING THE SYSTEM¿ EXPLAINS HOW TO PROPERLY USE THE MOBILE POWER UNIT AND IN THE EVENT THE MPU LOSES POWER THE PATIENT IS INSTRUCTED TO SWITCH POWER SOURCES AS THE BACKUP BATTERY IN THE SYSTEM CONTROLLER WILL ONLY TEMPORARILY POWER THE PUMP. HEARTMATE 3 PATIENT HANDBOOK AND HEARTMATE 3 INSTRUCTIONS FOR USE CAUTIONS THE USER 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. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. NO FURTHER INFORMATION INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: 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 EVENT LOG CAPTURED A LOW VOLTAGE HAZARD EVENT WHILE USING THE MPU. THE EVENT OCCURRED ON (B)(6) 2019 AND APPEARED TO BE DUE TO A TOTAL LOSS OF POWER TO THE MPU. NO OTHER UNUSUAL EVENTS WERE NOTED IN THE LOG FILE. NO FURTHER OR ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319028 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention