BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 24814509 · Received April 8, 2026

    Report

    Report Number
    2249723-2026-0002107
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 8, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW IT WAS DETERMINED THAT THE EVENT WAS ALREADY REPORTED IN MFG REPORT NO: 2249723-2026-0002080. PLEASE REFER MFG REPORT NO: 2249723-2026-0002080 FOR ALL EVENT RELATED INFORMATION. PLEASE CANCEL MFG REPORT NO: 2249723-2026-0002107 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTERIZATION LIMIT E1 EVENT SITE NAME: (B)(6). ANOTHER REPORTER: (B)(6). ANOTHER CONTACT INFO: (B)(6). 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

    IT WAS REPORTED BY THE CUSTOMER THROUGH EMERGENCY SUPPORT PROGRAM THAT THE CARDIOSAVE INTRA AORTIC BALLON PUMP(IABP) HAD DISCOLORATION IN THE HELIUM TUBING. ESP PERSONNEL RECOMMENDED REMOVING THE HELIUM TUBING FROM THE PUMP, NOTIFYING THE PHYSICIAN AND TO PREPARE FOR BALLOON CATHETER REMOVAL. ESP PERSONNEL ALSO VISUALIZED A VIDEO THAT SHOWED BLOOD REACHING THE PUMP. ESP PERSONNEL EXPLAINED TO MEGAN THAT THE BALLOON CATHETER SHOULD NOT REMAIN INACTIVE FOR GREATER THAN 30 MINUTES DUE TO POTENTIAL RISK OF THROMBUS. ESP PERSONNEL WAS UNABLE TO COLLECT PRODUCT SURVEILLANCE AT THE TIME OF CALL DUE TO MEGAN NEEDING TO PRIORITIZE PATIENT CARE AND ASKED HER TO KEEP THE CATHETER AND PUMP AT THE BEDSIDE. ESP PERSONNEL PROVIDED MEGAN WITH HIS PHONE NUMBER AND ASKED HER TO CALL DIRECTLY SHOULD SHE HAVE ANY OTHER QUESTIONS OR THE NEED FOR TROUBLESHOOTING ASSISTANCE. ESP PERSONNEL FOLLOWED UP WITH MEGAN, AND SHE REPORTED THE BALLOON CATHETER AND SHEATH HAD BEEN REMOVED SUCCESSFULLY. ESP PERSONNEL COLLECTED PRODUCT SURVEILLANCE AND EXPLAINED THAT A BIOHAZARD KIT WOULD BE SENT TO HER MANAGER AND REQUESTED THE CATHETER BE RETURNED TO GETINGE. ESP PERSONNEL ASKED MEGAN TO SEND THE PUMP TO BIOMED. NO HARM INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875616 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 58 YR Male SENSATION PLUS 50CC