BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110

    MDR report key: 6708266 · Received July 12, 2017

    Report

    Report Number
    3005168196-2017-01147
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    June 13, 2017
    Report Date
    June 13, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012773
    PMA / PMN Number
    K160449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INADVERTENTLY MISSED ON THE FOLLOW-UP #01 AND IS BEING INCLUDED ON THIS FOLLOW-UP #02 MFR REPORT. SECTION H. BOX 4. DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: BLOOD WAS PRESENT ON PUMP MAX HOUSING. THE PUMP MAX WAS NOT FUNCTIONALLY TESTED DUE TO THE RETURNED CONDITION (BLOOD INSIDE PUMP). CONCLUSIONS: EVALUATION OF THE RETURNED PUMP MAX CONFIRMED THAT BLOOD WAS INSIDE THE DEVICE. THIS TYPE OF DAMAGE LIKELY OCCURRED FROM THE MISCONNECTION OF THE ASPIRATION TUBING TO THE PUMP MAX THUS BYPASSING THE CANISTER. PENUMBRA PUMP MAXS ARE VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING INCOMING INSPECTION BY QUALITY. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION WAS UPDATED TO INDICATE THAT THE HOSPITAL STAFF DID NOT USE A PUMP MAX CANISTER.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF INADVERTENTLY MISCONNECTED THE ASPIRATION TUBING TO THE PUMP MAX AND, UPON ASPIRATION, BLOOD ENTERED THE PUMP MAX. THE PUMP MAX TURNED OFF ONCE BLOOD ENTERED THE DEVICE. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF DID NOT USE A PUMP MAX CANISTER AND INADVERTENTLY CONNECTED THE ASPIRATION TUBING TO THE PUMP MAX DIRECTLY AND, UPON ASPIRATION, BLOOD ENTERED THE PUMP MAX. THE PUMP MAX TURNED OFF ONCE BLOOD ENTERED THE DEVICE. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488563 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 NRY NRY PENUMBRA, INC. F12110-10 00814548012773

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR