BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 24596446 · Received March 13, 2026

    Report

    Report Number
    2249723-2026-0001651
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 19, 2026
    Report Date
    April 9, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723 2026 0001664. PLEASE REFER TO MFG REPORT NUMBER 2249723 2026 0001664 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723 2026 0001651 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723 2026 0001664. PLEASE REFER TO MFG REPORT NUMBER 2249723 2026 0001664 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723 2026 0001651 IN YOUR DATABASE.

    Description of Event or Problem · 0

    A DIRECT CALL WAS RECEIVED REGARDING CARDIOSAVE PUMP INVOLVING A GAS LOSS ALARM SETTING THAT COULD NOT BE TURNED BACK ON DURING USE. NO HARM OR INJURY WAS REPORTED. NATHALIE, A NURSE EDUCATOR SUPPORTING THE PRIMARY NURSE, ATTEMPTED MULTIPLE TIMES TO REACTIVATE THE GAS LOSS ALARM WITHOUT SUCCESS. TROUBLESHOOTING GUIDANCE WAS PROVIDED, BUT THE SETTING REMAINED UNRESPONSIVE. SHE PLANNED TO REMOVE THE CATHETER LATER THAT DAY AND TAKE THE PUMP OUT OF SERVICE AFTERWARD. COMPLAINT INFORMATION WAS COLLECTED, AND THE CALLER EXPRESSED APPRECIATION FOR THE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35837 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 76 YR Male IAB