BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18895342 · Received March 13, 2024

    Report

    Report Number
    2249723-2024-01069
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    March 2, 2024
    Report Date
    October 15, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H5).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6, H10. IT WAS LATER REPORTED BY THE CUSTOMER THAT THAT THE TOP PLUG WHERE THEY USUALLY CHARGE THE IABP WAS NOT WORKING. THE BOTTOM PLUG DOES WORK HOWEVER, AND CAN NOW SEE THE APPROPRIATE CHARGING ICON WITH THE GREY BATTERIES BOTH SIDES AND CHARGING EMOJI. THE PUMP WAS RETURNED TO UC MEDICAL CENTER OF THE ROCKIES, LOVELAND WHERE IT WAS SEQUESTERED FOR BIOMED. CUSTOMER HAS NOT REQUESTED SERVICE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER A TRANSPORT OF A PATIENT BY THE TRANSPORT TEAM, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HELIUM INDICATOR WENT FROM FULL TO A LOW HELIUM ALARM WITH ONLY 2 DISCONNECTIONS WHEN ARRIVED TO SWITCH THE PATIENT OVER TO THE RESCUE PUMP. ALSO, THE BATTERIES WERE NOT FULLY CHARGED. THE CUSTOMER WAS CONCERNED THERE WOULD NOT BE ENOUGH HELIUM AND BATTERY TO MAKE THE TRANSPORT, SO THEY SWITCHED THE PATIENT ONTO ANOTHER PUMP TO COMPLETE THE TRANSPORT. THERE WAS NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178351 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female