BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22912625 · Received August 28, 2025

    Report

    Report Number
    2249723-2025-0003615
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 10, 2025
    Report Date
    November 19, 2025
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. GAS LOSS IN IAB CIRCUIT: A GAS LOSS IN THE IAB CIRCUIT TAKES PLACE WHEN THE PUMP DETECTS A HELIUM LOSS DUE TO A LEAK OR HIGH RATE OF DIFFUSION IN THE IAB CIRCUIT. WHEN A CUMULATIVE SHUTTLE GAS LOSS EXCEEDS A NOMINAL 5 CC/HR DYNAMIC LIMIT A GAS LOSS ALARM IS TRIGGERED. THE ALARM ACTIVATES ONLY WHEN THE IAB INFLATION PERIOD >=80 MSEC AND DEFLATION PERIOD >=250 MSEC. CAUSES OF GAS LOSS IN IAB CIRCUIT: 1. LEAK, BLOOD IN CATHETER/BALLOON/EXTENDER TUBING. 2. LOOSE CONNECTIONS BETWEEN LUERS AND CONNECTORS. 3. PATIENT CONDITION SUCH AS (FEBRILE OR TACHYCARDIA). TREND REVIEW FOR ALL IABP PRODUCTS AND GAS GAIN/LOSS ALARM IS PERFORMED ON THE MONTHLY BASIS. IF ANY TRIGGERS ARE IDENTIFIED, THE TRIGGERS ARE DISCUSSED IN THE MONTHLY METRICS MEETING AND THE TRIGGERS IS INVESTIGATED IN THE CAPA REQUEST AS APPLICABLE. PER (B)(4) - CUSTOMER PRODUCT COMPLAINT INVESTIGATION, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS REQUIRED WHEN: COMPLAINT IS ORIGINATED FROM GERMANY AND SINGAPORE. COMPLAINT INCLUDES REPORTED SERIOUS INJURY OR DEATH. COMPLAINT DEVICE WAS MANUFACTURED WITHIN 1 YEAR OF EVENT DATE OR AWARE DATE WHEN EVENT DATE IS NOT AVAILABLE. COMPLAINTS CONFIRMED FOR A DEVICE MALFUNCTION CAUSED BY A MANUFACTURING DEFECT. FOR THIS PARENT INVESTIGATION, NO IABP OR IAB FAILURES WERE CONFIRMED AND THEREFORE NO DHR REVIEW IS REQUIRED, UNLESS AN ADVERSE EVENT IS REPORTED. SINCE THERE WAS NO IAB OR IABP MALFUNCTION IDENTIFIED, NO SCAR REVIEW NEEDS TO BE PERFORMED AT THIS TIME. TROUBLESHOOTING PERFORMED VIA PHONE WITH EMERGENCY SUPPORT. NO SERVICE/REPAIR PERFORMED OR PARTS REPLACED.

    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

    IT WAS REPORTED THAT DURING USE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD GAS LOSS ALARM. IT WAS SAYING EARLIER THAT THERE WAS A GAS LEAK DETECTED BUT THERE IS NO BLOOD IN THE TUBING, SO WE SEARCHED THE SITE, AND IT JUST CAME BACK. BUT IT WAS PAUSED FOR LIKE 10 MINUTES. IT WAS VERIFIED THERE WAS NO BLOOD IN THE HELIUM TUBING, ALL CONNECTIONS WERE SECURE AND APPROPRIATE AND THAT THERE WERE NO VISIBLE KINKS IN THE LINE. THE PATIENT¿S HEMODYNAMICS AND CLINICAL PICTURE, THE ALARM WAS LIKELY CAUSED BY PROLONGED TACHYCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2742500 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 46 YR Male IAB.