BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 11864504 · Received May 21, 2021

    Report

    Report Number
    2249723-2021-01078
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    April 4, 2021
    Report Date
    December 8, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS; B4, B6, G3, G6, G7, H2, H4, H6, H10, H11. CORRECTED FIELDS; D1, D4, D10. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO EVALUATE THE IABP UNIT BECAUSE A FOLLOW-UP CALL WAS PLACED SEVERAL MINUTES LATER AND THE RN REPORTS A NEW BALLOON WAS PLACED AND THE OLD ONE WAS DISCARDED. THE CUSTOMER WAS IN NO POSITION TO OBTAIN COMPLAINT INFORMATION AT THE TIME AND THE CALL ENDED. IF INFORMATION IS RECEIVED, WE WILL REOPEN AND UPDATE THE COMPLAINT.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IS BEING REQUESTED WITH REGARD TO THE REPAIR AND STATUS OF THE IABP. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THIS INFORMATION IS PROVIDED TO US.

    Description of Event or Problem · 1

    MEDWATCH MW5100645 RECEIVED FROM FDA ON 27APR2021 REPORTED: IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ALARM NOTED "NO GAS" AND IT WAS NOT INFLATING. ALL CONNECTIONS SECURE, NO EXTERNAL EVIDENCE OF LEAKAGE. RN AND CHARGE RN AT BEDSIDE. MD TO BEDSIDE AND REQUESTED ANOTHER BALLOON FOR EXCHANGE OF DEVICE. UPON REMOVAL OF PREVIOUSLY IMPLANTED BALLOON, NOTED TO HAVE LARGE HOLE. BALLOON PLACED IN BIOHAZARD BAG AND SAVED AS EVIDENCE OF EQUIPMENT FAILURE. PATIENT REMAINED GENERALLY HEMODYNAMICALLY STABLE. ALTHOUGH THERE WAS A SIGNIFICANT DROP IN SBP WHILE BALLOON OUT. PATIENT REQUIRED EMERGENT BEDSIDE SURGERY TO REPAIR FEMORAL ARTERY. PATIENT IS A (B)(6) YEAR OLD LADY WITH NO PREVIOUS CARDIAC HISTORY. SHE PRESENT TODAY FOR CHEST DISCOMFORT, DYSPNEA ON EXERTION. SHE STARTED NOTICING DYSPNEA EXERTION, CHEST DISCOMFORT WHEN SHE WAS WALKING AROUND 1 WEEK AGO. DENIES RESTING SYMPTOMS, NO ORTHOPNEA, NO PND, NO PRESYNCOPE OR SYNCOPE. SHE WENT TO SEE HER PCP EARLIER TODAY AS SCHEDULED. AN EKG WAS DONE, WHICH WAS CONCERNING FOR ACUTE CORONARY SYNDROME. SHE WAS SENT TO EMERGENCY ROOM IMMEDIATELY. SHE IS RESTING WITHOUT DISTRESS WHEN I SAW HER. NO CHEST PAIN, NO CHEST PRESSURE, NO ORTHOPNEA, NO PND. HER EKG SHOWED ST DEPRESSION, BUT NO INDICATION OF STEMI. SHE HAS BEEN HEMODYNAMICS STABLE. TROPONIN IS MILDLY ELEVATED. FDA SAFETY REPORT ID # (B)(4) THIS REPORT IS FOR THE CARDIOSAVE IABP. THE IAB CATHETER INVOLVED IN THIS EVENT IS REPORTED SEPARATELY ON MFG REPORT NUMBER 2248146-2021-00251.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759598 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention IAB| IAB SENSATION PUS 8FR. 50CC