BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V

    MDR report key: 5736969 · Received June 20, 2016

    Report

    Report Number
    3005168196-2016-00841
    Event Type
    Malfunction
    Date Received
    June 20, 2016
    Date of Event
    May 14, 2016
    Report Date
    May 22, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    UDI-DI
    00814548012773
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULT: THERE WAS NO VISIBLE DAMAGE TO THE EXTERIOR OF THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). WHEN THE PUMP MAX WAS RAN AT THE MAXIMUM VACUUM SETTING, THE VACUUM GAUGE ONLY REACHED -22 IN.HG. THE VACUUM TUBING WAS NOT COMPLETELY SEALED ON THE BRASS FITTING. THE PUMP MAX WAS PLUGGED IN AND POWERED ON AND RAN FOR 1 HOUR AND 30 MINUTES AND DID NOT SHUT OFF; HOWEVER, THE PUMP MAX GENERATED INSUFFICIENT VACUUM. AN EXTERNAL CALIBRATED GAUGE WAS CONNECTED TO THE PUMP MAX AND PUMP VACUUM WAS PRESENT. THE PUMP MAX HOUSING WAS OPENED BY A PENUMBRA INVESTIGATOR; IT WAS OBSERVED THAT PART OF THE VACUUM TUBING WAS NOT COMPLETELY SEALED ON THE BRASS FITTING. CONCLUSION: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE PUMP MAX WAS CAPABLE OF GENERATING VACUUM WHEN POWERED ON. THE PUMP MAX WAS CAPABLE OF RUNNING FOR 1 HOUR AND 30 MINUTES CONTINUOUSLY WITHOUT POWERING OFF. PER THE PENUMBRA ASPIRATION PUMP MAX INSTRUCTIONS FOR USE (IFU), RUNNING THE PUMP MAX CONTINUOUSLY FOR AN EXTENDED PERIOD OF TIME MAY CAUSE MAY CAUSE THE PUMP MAX TO SHUT OFF IF ADEQUATE AIRFLOW IS NOT PROVIDED. THE PUMP MAX MAY BE POWERED ON AGAIN AFTER ALLOWED TO COOL DOWN. INADEQUATE AIRFLOW MAY HAVE CAUSED THE PUMP MAX TO SHUT OFF DURING USE. FURTHER EVALUATION REVEALED THAT THE PUMP MAX GENERATED INSUFFICIENT VACUUM AND ONLY REACHED -22 IN.HG DURING THE FUNCTIONAL TEST. A CALIBRATED EXTERNAL GAUGE WAS CONNECTED TO THE PUMP MAX TO VERIFY THE ORIGINAL PUMP MAX GAUGE READING. THE CALIBRATED GAUGE VACUUM PRESSURE READING CONFIRMED THAT THE PUMP MAX HAD INSUFFICIENT VACUUM PRESSURE. THE PUMP MAX HOUSING WAS OPENED BY THE PENUMBRA INVESTIGATOR; IT WAS OBSERVED THAT PART OF THE VACUUM TUBING WAS NOT COMPLETELY SEALED ON THE BRASS FITTING. THE TUBING WAS PROPERLY RE-CONNECTED BY A PENUMBRA INVESTIGATOR AND THE VACUUM PRESSURE WAS WITHIN SPECIFICATION. THE TUBING NOT BEING COMPLETELY SEALED TO THE BRASS FITTING IS LIKELY THE ROOT CAUSE OF THE INSUFFICIENT VACUUM DURING EVALUATION. PUMPS ARE 100% FUNCTIONALLY TESTED DURING IN-PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CEREBRAL ARTERY USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). DURING THE PROCEDURE, THE PUMP MAX WAS WORKING CONTINUOUSLY FOR MORE THAN AN HOUR AND THEN STOPPED WORKING. THE PHYSICIAN ATTEMPTED TO TURN THE PUMP MAX ON AGAIN; HOWEVER, THE PUMP MAX WOULD NOT WORK AT ALL. THE PROCEDURE ENDED AT THIS POINT SINCE THE THROMBUS HAD ALREADY BEEN ASPIRATED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390877 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX JCX PENUMBRA, INC. F08202-23 00814548012773

    Patients

    Seq Age Sex Outcome Treatment
    1