BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 128119 · Received October 21, 1997

    Report

    Report Number
    2248146-1997-01120
    Event Type
    Malfunction
    Date Received
    October 21, 1997
    Date of Event
    October 2, 1997
    Report Date
    October 10, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABEL CODE FOR F10. POSITION 1 AND 2: 1738, AND POSITION 3: 1701. THE PRODUCT HAS NOT YET BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    EVENT: (CC# 97-01146) AFTER IAB FOR TWO TO THREE DAYS, THE IAB LEAKED. THE IAB WAS REMOVED AND A SECOND WAS INSERTED. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 97-01147) ON 10/27/1997, DATASCOPE RECEIVED THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT NUMBER: 33-0119 1997 0005. THE FOLLOWING WAS INFO WAS REPORTED: THE PT WAS ADMITTED WITH MYOCARDIAL INFARCTION AND WENT INTO CARDIOGENIC SHOCK. AN IAB WAS INSERTED INTO THE PT ON 9/22/1997. ON 10/2/1997, AN ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE CATHETER. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PT ON 10/3/1997. DATASCOPE WAS ALSO NOTIFIED ON 10/27/1997 THAT THE IAB WAS AVAILABLE TO BE RETURNED FOR EVALUATION. ON 10/28/1997, DATASCOPE WAS NOTIFIED THAT THE PT EXPIRED. ON 12/18/1997 IT WAS REPORTED THAT THE PT WAS ADMITTED WITH MYOCARDIAC INFARCTION AND WENT INTO CARDIOGENIC SHOCK. AN IAB WAS INSERTED AND BLOOD WAS EVENTUALLY NOTED IN THE CATHETER AND THE IAB WAS REMOVED. ON 10/3/1997, A NEW IAB WAS INSERTED INTO THE PT. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PT EXPIRED ON 10/3/1997 BUT THE PT'S DEATH WAS NOT IAB RELATED. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 10/10/1997, 10/27/1997; NONE - RPT'D 12/18/1997. [PT'S CURRENT STATUS]: EXPIRED RPT'D 12/18/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-0206-01 7/3/99

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR