BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSAVE HYBRID

    MDR report key: 10118897 · Received June 4, 2020

    Report

    Report Number
    2249723-2020-00854
    Event Type
    Injury
    Date Received
    June 4, 2020
    Date of Event
    April 30, 2020
    Report Date
    July 28, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G4, G7, H2, H6 (EVALUATION METHOD CODES), H10, H11 CORRECTED FIELDS: B5, G5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON PUMP (IABP) THERAPY WHICH WAS INITIATED ON (B)(6) 2020, THE IABP CONSOLE GENERATED A "GAS LOSS IN IAB CIRCUIT" ALARM AND BLOOD LEAKAGE WAS OBSERVED WITHIN THE TRANS-RAY 50CC INTRA-AORTIC BALLOON CATHETER (IABC) ON (B)(6) 2020. ON (B)(6) 2020 THE IABC WAS REMOVED FROM THE PATIENT; HOWEVER, AFTER REMOVAL OF THIS IABC, THE PATIENT'S BLOOD PRESSURE WAS DECREASED TEMPORARILY. LATER ON, THE BLOOD PRESSURE BECAME STABLE. THERE WAS NO INFORMATION AVAILABLE ABOUT HOW LONG IT TOOK FOR THE PATIENT'S BLOOD PRESSURE TO BE STABLE OR WHETHER THE PATIENT THE DECREASED BLOOD PRESSURE WAS TREATED WITH A VASOPRESSOR AGENT. HOWEVER, THE IABP THERAPY ENDED WITHOUT USING A SECOND IABC. THERE WAS NO REPORTED MALFUNCTION OF THE IABP AND THE DROP IN THE BLOOD PRESSURE IS NOT ATTRIBUTED TO THE IABP AS THE PATIENT'S BP DROPPED POST IABP THERAPY. REFER TO MFG REPORT NUMBER 2248146-2020-00261FOR INFORMATION ON THE INVOLVED IABC.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS IABP UNIT CANNOT BE REVIEWED PER THE SOP SINCE THE SERIAL NUMBER FOR THE UNIT WAS NOT PROVIDED. THERE WAS NO REPORTED MALFUNCTION OF THE INVOLVED IABP, AND THE MODEL AND SERIAL NUMBER WAS NOT PROVIDED TO US. IN ADDITION, A GETINGE REPRESENTATIVE HAS ADVISED THAT THE IABP THERAPY WAS INITIATED FOR THE TREATMENT OF REDUCTION IN BLOOD PRESSURE AND THAT NO ANOMALIES OR MALFUNCTION WAS FOUND ON THE IABP UNIT. NO REPAIR FOR THE IABP UNIT IS NOT REQUIRED, AND THE IABP UNIT IS BEING USED CURRENTLY AND NORMALLY AT THIS FACILITY. NO FURTHER INVESTIGATION IS REQUIRED. NOT RETURNED TO MANUFACTURER

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON PUMP (IABP) THERAPY WHICH WAS INITIATED ON (B)(6) 2020, THE IABP CONSOLE GENERATED A "GAS LOSS IN IAB CIRCUIT" ALARM AND BLOOD LEAKAGE WAS OBSERVED WITHIN THE INTRA-AORTIC BALLOON CATHETER (IABC) ON (B)(6) 2020. ON (B)(6) 2020 THE IABC WAS REMOVED FROM THE PATIENT; HOWEVER, AFTER REMOVAL OF THIS IABC, THE PATIENT'S BLOOD PRESSURE WAS DECREASED TEMPORARILY. LATER ON, THE BLOOD PRESSURE BECAME STABLE. THERE WAS NO INFORMATION AVAILABLE ABOUT HOW LONG IT TOOK FOR THE PATIENT'S BLOOD PRESSURE TO BE STABLE OR WHETHER THE PATIENT THE DECREASED BLOOD PRESSURE WAS TREATED WITH A VASOPRESSOR AGENT. HOWEVER, THE IABP THERAPY ENDED WITHOUT USING A SECOND IABC. THERE WAS NO REPORTED MALFUNCTION OF THE IABP AND THE DROP IN THE BLOOD PRESSURE IS NOT ATTRIBUTED TO THE IABP AS THE PATIENT'S BP DROPPED POST IABP THERAPY. REFER TO MFG REPORT NUMBER 2248146-2020-00261FOR INFORMATION ON THE INVOLVED IABC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584694 CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TRANSRAY PLUS 50CC LOT # 3000106388| TRANSRAY PLUS 50CC LOT # 3000106388