BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG

    MDR report key: 19706078 · Received July 9, 2024

    Report

    Report Number
    2916596-2024-04231
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    May 21, 2024
    Report Date
    September 27, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF FLUID INGRESS IN THE SHOWER BAG WAS CONFIRMED VIA THE ADDITIONAL INFORMATION. A REVIEW OF THE SUBMITTED CONTROLLER EVENT LOG FILE (113357) SPANNED APPROXIMATELY 4 DAYS (15JUN2024 ¿18JUN2024 PER TIME STAMP). THE LOG FILE DID NOT CONTAIN DATA FROM THE REPORTED EVENT DATE OF 21MAY2024. THERE WERE NO NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE SHOWER BAG WAS NOT RETURNED FOR ANALYSIS AND REMAINS IN USE. THE PROVIDED INFORMATION STATED THAT THE PATIENT¿S SHOWER BAG HAD WATER INTRUSION WHEN THEY WERE BATHING AND THE CONTROLLER ALARMED FOR LOW BATTERY EVEN THOUGH THEY HAD NEW BATTERIES CONNECTED. LOG FILES WERE SUBMITTED, HOWEVER THE EVENT WAS 4 WEEKS PRIOR TO WHEN THE LOG FILES WERE DOWNLOADED. NO WATER WAS SEEN IN THE CONTROLLER AND THE PATIENT DID NOT SAY THE SHOWER BAG WAS DAMAGED. THEY WERE SUBMERGING THEMSELVES IN A BATH. NO PRODUCTS WERE EXCHANGED. THERE WERE NO PHOTOS PROVIDED. PER THE ADDITIONAL INFORMATION, THE ROOT CAUSE OF THE REPORTED FLUID INGRESS WAS DUE TO USER ERROR BY TAKING A BATH. 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. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 4-¿LIVING WITH THE HEARTMATE 3¿ STATES THAT ¿THE HEARTMATE 3 SYSTEM COMPONENTS MUST BE KEPT DRY. NEVER EXPOSE THE SYSTEM CONTROLLER, BATTERIES, MOBILE POWER UNIT OR POWER BASE UNIT TO WATER. IF THESE SYSTEM COMPONENTS GET WET, YOUR PUMP MAY STOP. NEVER TAKE TUB BATHS OR GO SWIMMING WHILE IMPLANTED WITH THE PUMP. THE HEARTMATE® GOGEAR® SHOWER BAG MUST BE USED WHILE SHOWERING TO KEEP THE SYSTEM CONTROLLER AND BATTERIES DRY.¿ UNDER SECTION 1, ¿INTRODUCTION¿, WARNS USERS ¿DO NOT TAKE SHOWERS UNLESS APPROVED BY A DOCTOR FOR SHOWERING. IF APPROVED FOR SHOWERING, THE SHOWER BAG MUST BE USED FOR EVERY SHOWER. THE SHOWER BAG PROTECTS OUTSIDE PARTS OF THE SYSTEM FROM WATER OR MOISTURE. IF OUTSIDE PARTS OF THE SYSTEM GET WET, THE PUMP MAY STOP.¿ UNDER SECTION 4, ¿LIVING WITH THE HEARTMATE 3¿, DETAILS DESCRIPTIONS HOW TO PROPERLY USE THE SHOWER BAG ARE OUTLINED. ALSO CAUTION USER THAT ¿ALTHOUGH THE EXTERNAL COMPONENTS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM ARE MOISTURE-RESISTANT, THEY ARE NOT WATERPROOF. TAKE CARE TO PROTECT SYSTEM COMPONENTS FROM WATER OR MOISTURE, WHETHER INDOORS SHOWERING OR OUTDOORS IN A HEAVY RAIN. IF THE COMPONENTS HAVE CONTACT WITH WATER OR MOISTURE, YOU MAY RECEIVE A SERIOUS ELECTRICAL SHOCK OR THE PUMP MAY STOP.¿ NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT STATED THEIR SHOWER BAG HAD WATER INTRUSION WHEN THEY WERE BATHING AND THEIR VENTRICULAR ASSIST DEVICE (VAD) ALARMED STATING LOW BATTERY EVEN THOUGH THEY HAD NEW BATTERIES ON. THERE WERE NO OTHER ALARMS OR ISSUES SINCE. NO EQUIPMENT HAD BEEN REPLACED AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION STATED THAT NO WATER WAS SEEN IN THE SYSTEM CONTROLLER AND THE CONTROLLER WAS NOT EXCHANGED. THE PATIENT DID NOT SAY THE SHOWER BAG WAS DAMAGED; THEY WERE SUBMERGING THEMSELF IN A BATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973755 THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 104232 00813024011149

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male