BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 16777835 · Received April 20, 2023

    Report

    Report Number
    2916596-2023-02084
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    April 3, 2023
    Report Date
    July 18, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G3: THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE PMA # PROVIDED IS ASSOCIATED WITH MOST RECENT APPROVAL. MANUFACTURER'S INVESTIGATION CONCLUSION. THE REPORTED EVENT OF NO VISUAL LIGHTS ON THE MOBILE POWER UNIT (MPU) WAS CONFIRMED VIA EVALUATION. THE HEARTMATE MOBILE POWER UNIT (S/N: (B)(6)) WAS INSPECTED AT THE SERVICE DEPOT. VISUAL INSPECTION REVEALED THAT THE LED OVERLAY LABEL WAS PLACED INVERTED 180 DEGREES FROM THE CORRECT POSITION. THE MPU WAS PLUGGED IN TO AN AC POWER SOURCE AND THE REPORTED EVENT WAS CONFIRMED, THE LED INDICATORS WERE NOT VISIBLE DUE TO THE LED OVERLAY BEING INSTALLED INCORRECTLY. THE CUSTOMER WAS PROVIDED A WARRANTY REPLACEMENT AND THE RETURNED MPU WAS FORWARDED TO THE PRODUCT PERFORMANCE ENGINEERING (PPE) GROUP. THE MPU UNDERWENT FURTHER TESTING. THE UNIT WAS DISASSEMBLED, AND THE OVERLAY LABEL WAS OBSERVED TO BE COVERING THE LED INDICATOR WINDOWS. THE UNIT WAS CONNECTED TO AC POWER AND THE LED PRINTED CIRCUIT BOARD (PCB) WAS FOUND TO OPERATE AS INTENDED. A MANUFACTURING TASK WAS OPENED TO INVESTIGATE THE LED OVERLAY ISSUE. A ROOT CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE THE OVERLAY LABEL BEING INCORRECTLY PLACED DURING THE MANUFACTURING PROCESS DUE TO OPERATOR ERROR. AN AWARENESS TRAINING WAS CONDUCTED FOR OPERATORS ASSIGNED TO THE MPU FINAL ASSEMBLY PRODUCTION LINE. HEARTMATE 3 PATIENT HANDBOOK, REV. D, SECTION 10 ¿SAFETY CHECKLISTS¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU), REV. C, SECTION E ¿SAFETY CHECKLISTS¿ PROVIDE THE USER WITH CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF ALL COMPONENTS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE, INCLUDING THE MPU. HEARTMATE 3 INSTRUCTIONS FOR USE, REV. C, SECTION 3-¿POWERING THE SYSTEM¿ STATES THAT IF THE GREEN ¿POWER ON¿ LIGHT DOES NOT COME ON, THE MOBILE POWER UNIT MAY HAVE A PROBLEM. DO NOT USE A DEFECTIVE DEVICE. CONTACT THORATEC CORPORATION FOR A REPLACEMENT, IF NEEDED. THE PATIENT HANDBOOK CAUTIONS 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. DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS; HOWEVER, IT WAS DETERMINED THAT THE DHR DOCUMENTATION WAS COMPLETED INCORRECTLY AND HAS BEEN ADDRESSED VIA MANUFACTURING ANALYSIS. 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 COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, EVEN THOUGH THE BATTERIES WERE INSTALLED AND THE MOBILE POWER UNIT (MPU) WAS PLUGGED IN, THE ALARM STILL DID NOT WORK AS INTENDED: AN AUDIO TEST ALARM WAS HEARD, BUT THERE WAS NO VISUAL LIGHT. THE MPU WAS NOT ISSUED TO A NEW PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205939 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown