BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET-GETINGE BALLOON PUMP

    MDR report key: 10829328 · Received November 10, 2020

    Report

    Report Number
    MW5097803
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    November 1, 2020
    Report Date
    November 6, 2020
    Manufacturer
    GETINGE US SALES LLC / DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PT WAS IN THE CVICU THE PT TURNED IN BED AND BLOOD WAS NOTED IN THE IABP (WHICH WAS PLACED ON (B)(6) 2020). THE CATH LAB TEAM WAS CALLED IN TO REMOVE THE IABP UNDER FLUOROSCOPY. THE INTERVENTIONAL CARDIOLOGIST WAS UNABLE TO REMOVE THE IABP END CALLED VASCULAR SURGERY. VASCULAR SURGERY TOOK THE PATIENT TO THE OR END DID A CUT DOWN TO REMOVE THE BALLOON. IT WAS NOTED THAT THE BALLOON WAS RUPTURED UND DID NOT DEFLATE COMPLETELY CAUSING A TEAR IN THE FEMORAL ARTERY. THE ARTERY WAS PATCHED SUCCESSFULLY WITHOUT COMPLICATION. PLAQUE WAS NOTED IN THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279724 MAQUET-GETINGE BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP GETINGE US SALES LLC / DATASCOPE CORP. SENSATION PLUS 8F 50ML 300126212

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR