BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ASPIRATION PUMP

    MDR report key: 2397763 · Received January 4, 2012

    Report

    Report Number
    3005168196-2012-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    December 5, 2011
    Report Date
    December 5, 2011
    Manufacturer
    PENUMBRA, INC
    Product Code
    JCX
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE FILTER ATTACHMENT FITTING HAS PLASTIC EMBEDDED IN ITS THREADS. THE PUMP WAS PLUGGED INTO 110 VAC AND TURNED ON. THE PUMP OPERATED AS EXPECTED AND ACHIEVED A MAXIMUM VACUUM OF -27.0 IN HG WHEN THE INLET WAS BLOCKED WITH A GLOVED FINGER. A FILTER WAS INSERTED WITH DIFFICULTY. THE VACUUM ACHIEVED WITH THE FILTER INSTALLED WAS -25.0 IN HG. THIS IS WITHIN SPECIFICATION. CONCLUSION: THE DIFFICULTY INSTALLING THE FILTER NOTED IN THE COMPLAINT IS CONFIRMED. THE MATERIAL IN THE FITTING THREADS CREATED THIS DIFFICULTY AND IS MOST LIKELY THE RESULT OF OVER TIGHTENING OF THE FILTER IN THE FITTING, RESULTING IN BINDING OF THE BODY OF THE FILTER ONTO THE FITTING THREADS.

    Description of Event or Problem · 1

    THE TECHNOLOGIST WAS HAVING DIFFICULTY WITH THE NUT THAT THE FILTER SCREWS ONTO ON THE PUNUMBRA ASPIRATION PUMP. THE NUT IS STRIPPED AND WILL NO LONGER ACCEPT A FILTER. THE PUMP WAS REPLACED. NO PATIENT WAS INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1