BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP

    MDR report key: 1963564 · Received December 20, 2010

    Report

    Report Number
    3005168196-2010-00710
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE WAS REPAIRED ON SITE AND IS STILL IN USE.

    Description of Event or Problem · 1

    THE HOSPITAL STAFF NOTICED THAT THE ASPIRATION PUMP WAS NOT PROVIDING -25 INHG VACUUM. THEY CONTACTED THE PENUMBRA SALES REPRESENTATIVE TO TRY UNDERSTAND THE ISSUE BUT ENDED UP USING THE BACKUP PUMP INSTEAD. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE SUCCESSFULLY. WHEN THE PENUMBRA SALES REPRESENTATIVE ARRIVED AT THE HOSPITAL HE FOUND THAT THERE WAS A LOOSE NUT INSIDE THE PUMP HOUSING. HE WAS ABLE TO TIGHTEN THE NUT AND DECIDED TO TEST THE PUMP WHEN HE FOUND THAT THE ASPIRATION ADJUSTMENT KNOB WAS STRIPPED. HE WAS ABLE TO TIGHTEN THE KNOB AND THE PUMP WAS THEN ABLE TO PROVIDE ADEQUATE ASPIRATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1