BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA 7.5FR. 40CC IAB

    MDR report key: 16494590 · Received March 7, 2023

    Report

    Report Number
    2248146-2023-00159
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 16, 2023
    Report Date
    June 13, 2023
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567107974
    PMA / PMN Number
    K120868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND COULD NOT BE EVALUATED. IT WAS DISCARDED BY THE USER. WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. COMPLAINT RECORD ID # (B)(4).

    Additional Manufacturer Narrative · 0

    NO DECON OR VISUAL INSPECTION PERFORMED SINCE PRODUCT WAS NOT RETURNED AND COULD NOT BE EVALUATED. HOWEVER, TWO PHOTOGRAPHS WERE PROVIDED BY THE FACILITY WHERE BLOOD CAN BE SEEN INSIDE THE MEMBRANE, CATHETER TUBING, EXTRACORPOREAL TUBING, AND EXTENDER TUBING. WE ARE ABLE TO CONFIRM THE REPORTED PROBLEMS. HOWEVER, WITHOUT THE DEVICE RETURNED, WE ARE UNABLE TO DETERMINE A ROOT CAUSE. REFERENCE COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), THE CONSOLE GENERATED A CATHETER RESTRICTION ALARM. IT WAS DISCOVERED THAT THE IAB HAD BEEN TORN UPON INSERTION. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659740 MEGA 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 0684-00-0295-01 UNKNOWN 10607567107974

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female