BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSTAVAC

    MDR report key: 16126927 · Received January 9, 2023

    Report

    Report Number
    1419185-2023-00001
    Event Type
    Death
    Date Received
    January 9, 2023
    Date of Event
    December 4, 2022
    Report Date
    February 17, 2023
    Manufacturer
    OHIO MEDICAL LLC
    Product Code
    BTA
    UDI-DI
    00628101609504
    PMA / PMN Number
    K933902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 21, 2022: DISCUSSION WITH PUMP MANUFACTURER TOOK PLACE IN WHICH MULTIPLE FAILURE MODES FOR FRACTURED VANES WERE OUTLINED. ON DECEMBER 22, 2022: INVESTIGATION (B)(4) WAS INITIATED. ON DECEMBER 19, 2022: (B)(6) CONTACTED USER FACILITY REQUESTING ADDITIONAL INFORMATION WHICH INCLUDED DETAILS OF THE EVENT, AS WELL AS USAGE AND MAINTENANCE OF THE DEVICE. (B)(6) CONTINUED TO FOLLOW UP WITH THE USER FACILITY BY PHONE AND EMAIL ON DECEMBER 21, 2022, DECEMBER 27, 2022, DECEMBER 29, 2022, AND JANUARY 4, 2023. ON JANUARY 5, 2023: RESPONSE FROM USER FACILITY WAS RECEIVED. THE PATIENT WAS NOT PRODUCING SPONTANEOUS PULSE OR BREATH, AND PATIENT PROJECTILE VOMITED WHICH REQUIRED USE OF THE SUCTION PUMP. SECONDARY DEVICE WAS PUT INTO USE, BUT PATIENT WAS NOT ABLE TO BE RESUSCITATED. ADDITIONAL INVESTIGATION IS ONGOING TO DETERMINE DEFINITIVE ROOT CAUSE. A FOLLOW UP TO THIS REPORT WILL BE SUBMITTED AS REQUIRED BY 21 CFR 803 ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ADDITIONAL ACTIONS HAVE TAKEN PLACE: JANUARY 3, 2023 - INVESTIGATION (B)(4) CONCLUDED THAT MANUFACTURER RECOMMENDED PUMP MAINTENANCE WAS NOT INCLUDED IN OHIO MEDICAL DEVICE INSTRUCTIONS FOR USE, AND THEREFORE NOT PERFORMED, RESULTING IN CLOGGED EXHAUST MUFFLERS, INCREASED PRESSURE AND CRACKED VANES. JANUARY 18, 2023 - HEALTH AND HAZARD EVALUATION WAS COMPLETED, WITH CORRECTIONS IDENTIFIED AS REVISION OF OHIO MEDICAL INSTRUCTIONS FOR USE ALIGNING PREVENTIVE MAINTENANCE INSTRUCTIONS WITH PUMP MANUFACTURER RECOMMENDATIONS. JANUARY 30, 2023 - PUMP MANUFACTURER CONDUCTED EVALUATION OF A SAMPLE OF SEIZED PUMPS AND IDENTIFIED MANUFACTURING DEFECTS WITHIN THE PUMP COMPONENT UNRELATED TO PREVENTIVE MAINTENANCE OR DEVICE USE. IN ONE INSTANCE FAILURE OF THE ADHESIVE BOND BETWEEN THE MOTOR SHAFT AND THE ROTOR WAS NOTED, AND ANOTHER CASE IDENTIFIED AN ACTUAL MOTOR FAILURE. FURTHER INVESTIGATION INTO BOTH ISSUES IS REQUIRED. IT SHOULD BE NOTED THAT PRODUCT HOLD WAS INITIATED ON DECEMBER 20, 2022 FOR ALL POTENTIALLY IMPACTED PART NUMBERS. THIS HOLD WILL REMAIN IN PLACE UNTIL DEFINITIVE ROOT CAUSE, CORRECTION AND CORRECTIVE ACTION IS DETERMINED.

    Description of Event or Problem · 0

    COMPLAINT (B)(4) WAS RECEIVED ON DECEMBER 8, 2022 WHICH STATED "UNIT WAS BROUGHT IN DURING A CODE AND WAS NOT OPERATIONAL/ NO POWER. ANOTHER WORKING UNIT WAS BROUGHT IN."

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP TO REPORT SUBMITTED ON JANUARY 06, 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345657 INSTAVAC PORTABLE SUCTION PUMP BTA OHIO MEDICAL LLC 756010 INSTI22001 00628101609504

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death