BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP

    MDR report key: 2021347 · Received February 8, 2011

    Report

    Report Number
    3005168196-2011-00026
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 12, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THE PUMP HAS A BENT LOWER CHASSIS AT ONE OF THE MOUNTING SCREWS. THE REST OF THE EXTERIOR APPEARS NORMAL FOR A USED PUMP. OPENING THE CHASSIS THERE IS NOTHING VISIBLY UNUSUAL INSIDE THE PUMP. RESULTS: THE PUMP WAS PLUGGED IN AND TURNED ON. THE PUMP FUNCTIONED AS EXPECTED. THE PRESSURE ADJUSTMENT KNOB WAS TURNED AND MOVED FREELY. THE PUMP WAS RETURNED TO PENUMBRA ADJUSTED FOR MAXIMUM VACUUM, WHICH MEASURED >30 IN HG ON THE PUMP GAUGE. BASED ON THE DESCRIPTION OF THE COMPLAINT (BURNING RUBBER AND VISIBLE SMOKE), THE UNIT WAS RUN FOR 15 MINUTES UNDER CLOSE OBSERVATION. NO SMOKE WAS OBSERVED NOR WAS ANY BURNT RUBBER SMELL PERCEIVED. TO FURTHER STRESS THE UNIT AND SIMULATE WORST CASE CONDITIONS, THE UNIT WAS PLACED ON A FOLDED SURGICAL DRAPE TO BLOCK THE INLET AIR VENT AND RUN AT MAXIMUM VACUUM FOR 15 MINUTES. AGAIN NO SMOKE WAS OBSERVED AND NO BURNT RUBBER SMELL WAS PERCEIVED. THE METAL ON THE PUMP MOTOR HOUSING WAS WARM TO THE TOUCH BUT NOT UNEXPECTED. CONCLUSION CODE: WE WERE UNABLE TO CONFIRM THE COMPLAINT. BASED ON THE DAMAGE TO THE LOWER CHASSIS OF THE PUMP, IT APPEARS THAT THE PUMP MAY HAVE BEEN DAMAGED AT SOME POINT. THIS DAMAGE DOES NOT AFFECT THE PERFORMANCE OF THE PUMP.

    Description of Event or Problem · 1

    THE LAB MGR REPORTED THAT THE PENUMBRA SYSTEM ASPIRATION PUMP BEGAN TO SMELL LIKE BURNING RUBBER DURING A STROKE CASE, AND THE NURSING NOTED SMOKE COMING FROM THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM ASPIRATION PUMP BTA & JCX BTA PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1