BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 21512738 · Received March 4, 2025

    Report

    Report Number
    2249723-2025-0000968
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 12, 2025
    Report Date
    April 16, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 FULL EVENT SITE NAME: (B)(6) HOSPITAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2025-0000980. PLEASE REFER TO MFG REPORT NUMBER 2249723-2025-0000980 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0000968 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONCE THE CATHETER WAS IN, CARDIOSAVE INTRA AORTIC BALLOON PUMP(IABP) FAILED ZEROING PRIOR TO PUMPING. THEY THEN NOTICED THAT THE RED TIPPED PRESSURE CABLE HAD A BENT PIN AND SEVERAL LOOSE PINS. THEY QUICKLY SWITCHED THAT PUMP WITH CS300. AT THIS POINT THEY WERE ABLE TO ZERO BUT RECEIVED AN "AUTOFILL FAILURE" ALARM. AFTER SEVERAL ATTEMPTS TO REMEDY, THEY REMOVED THE IAB CATHETER AND REPLACED IT WITH ANOTHER CATHETER OF SAME SIZE AND TYPE. AGAIN, THEY RECEIVED THE AUTOFILL FAILURE ALARM AND COULD NOT REMEDY. THERE WAS NO HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346707 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-45 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male CS300, 2 IAB CATHETERS