BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 12068070 · Received June 25, 2021

    Report

    Report Number
    2916596-2021-03351
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    March 14, 2021
    Report Date
    June 25, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF LOW VOLTAGE ALARMS WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) WAS CONFIRMED VIA THE SUBMITTED LOG FILE. THE LOG FILE CONTAINED APPROXIMATELY 17 DAYS OF DATA (26FEB2021 ¿ 15MAR2021 PER THE TIMESTAMP). THE LOG FILE CAPTURED THE CONTROLLER BEING CONNECTED TO THE MPU ON 14MAR2021 AT 14:24:02. APPROXIMATELY 5 MINUTES LATER, A LOW VOLTAGE ADVISORY ALARM ACTIVATED DUE TO THE RELATIVE STATE OF CHARGE (RSOC) VOLTAGE LEVEL ON BOTH POWER CABLES DROPPING TO APPROXIMATELY 1.4 V. THE EXPECTED RSOC VOLTAGE WHILE CONNECTED TO THE MPU IS APPROXIMATELY 12.8 V. THIS SEQUENCE OF EVENTS IS CONSISTENT WITH THE CONTROLLER¿S POWER CABLES BEING INCORRECTLY CONNECTED TO THE OPPOSITE CONNECTORS OF THE MPU (BLACK POWER CABLE CONNECTED TO WHITE POWER CABLE AND VICE VERSA). A LOW VOLTAGE HAZARD ALARM WAS THEN ACTIVE FROM 14:30:21 TO 14:30:25 DUE TO THE WHITE POWER CABLE BEING DISCONNECTED WHILE THE LOW VOLTAGE CONDITION WAS ACTIVE ON THE BLACK POWER CABLE. THE WHITE POWER CABLE WAS THEN RECONNECTED TO THE MPU, AND THE LOW VOLTAGE ADVISORY ALARM REACTIVATED. THE LOW VOLTAGE ADVISORY ALARM RESOLVED AT 14:53:05 AFTER THE WHITE SYSTEM CONTROLLER POWER CABLE WAS CONNECTED TO A 14V BATTERY. THE CONTROLLER WAS CONNECTED TO THE MPU SEVERAL OTHER TIMES THROUGHOUT THE LOG FILE WITHOUT ANY ISSUES OR ATYPICAL ALARMS. THE ALARMS DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. ADDITIONAL INFORMATION PROVIDED STATED THAT THE MPU IS OPERATIONAL AND WILL NOT BE RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE USER ERROR IN THE CONNECTION OF THE CONTROLLER¿S POWER CABLES TO THE MPU; THE WHITE CONTROLLER POWER CABLE CONNECTOR WAS CONNECTED TO THE BLACK MPU PATIENT CABLE CONNECTOR AND THE BLACK CONTROLLER POWER CABLE CONNECTOR WAS CONNECTED TO THE WHITE MPU PATIENT CABLE CONNECTOR. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN IMPLEMENTED TO ADDRESS THE ISSUE OF SWAPPED CONNECTIONS TO THE MPU RESULTING IN ALARMS. THE MPU ASSOCIATED WITH THIS EVENT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THE CAPA. HEARTMATE 3 PATIENT HANDBOOK (REV. C), UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C), UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE LOW VOLTAGE ADVISORY ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 PATIENT HANDBOOK (REV. C) AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C) SECTION 3 ¿POWERING THE SYSTEM¿ EXPLAINS HOW TO USE ALL POWER SOURCES, INCLUDING THE MPU. THIS SECTION INFORMS THE USER TO CONNECT THE WHITE SYSTEM CONTROLLER POWER CABLE CONNECTOR TO THE WHITE MPU PATIENT CABLE CONNECTOR AND THE BLACK SYSTEM CONTROLLER POWER CABLE CONNECTOR TO THE BLACK MPU PATIENT CABLE CONNECTOR. HEARTMATE 3 PATIENT HANDBOOK (REV. C) CAUTIONS 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. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE MPU, SERIAL NUMBER (B)(4), WAS SHIPPED TO THE CUSTOMER ON 23NOV2016. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBMITTED LOG FILE REVEALED A LOW VOLTAGE ADVISORY ALARM ON 14MAR2021 DUE TO THE CONTROLLER¿S POWER CABLES BEING INCORRECTLY CONNECTED TO THE OPPOSITE CONNECTORS OF AN MPU (BLACK POWER CABLE CONNECTED TO WHITE POWER CABLE AND VICE VERSA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967336 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR