BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16707635 · Received April 10, 2023

    Report

    Report Number
    2249723-2023-01854
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 23, 2023
    Report Date
    April 3, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H10. ADDITIONAL INFORMATION: (B)(6). IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A CONDENSATION RELATED MALFUNCTION. LIZ, ARNP CALLED REGARDING CONDENSATION BUILD UP IN THE HELIUM TUBING. SHE STATED THEY HAD ALREADY SWITCHED TO A DIFFERENT PUMP AND CHANGED THE HELIUM EXTENDER TUBING AND THE CONDENSATION WAS VISIBLE AGAIN. FSE INSTRUCTED HER TO DISCONNECT THE EXTENDER TUBING FROM THE CATHETER AND THE PUMP, APPLY SUCTION TO REMOVE THE CONDENSATION, THEN RECONNECT AND RESUME THERAPY. ALARM LOG ON THE INITIAL PUMP SHOWED THEY RECENTLY HAD AN AUTOFILL FAILURE ALARM AND AN AUTOFILL FAILURE-BLOOD DETECTED ALARM. NO ALARMS OR MESSAGES APPEARED AFTER SWITCHING TO DIFFERENT PUMP. NO FURTHER INFORMATION AVAILABLE. H3 OTHER TEXT : FSE DID NOT WENT ONSITE TO PERFORM REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) CUSTOMER CALLED REGARDING CONDENSATION BUILD UP IN THE HELIUM TUBING. STATED THEY HAD ALREADY SWITCHED TO A DIFFERENT PUMP AND CHANGED THE HELIUM EXTENDER TUBING AND THE CONDENSATION WAS VISIBLE AGAIN. INSTRUCTED THE EXTENDER TUBING FROM THE CATHETER AND THE PUMP, APPLY SUCTION TO REMOVE THE CONDENSATION, THEN RECONNECT AND RESUME THERAPY. ALARM LOG ON THE INITIAL PUMP SHOWED THEY RECENTLY HAD AN AUTOFILL FAILURE ALARM AND AN AUTOFILL FAILURE-BLOOD DETECTED ALARM. NO ALARMS OR MESSAGES APPEARED AFTER SWITCHING TO DIFFERENT PUMP. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795373 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown UNKNOWN.