BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40CC. IAB

    MDR report key: 168266 · Received May 14, 1998

    Report

    Report Number
    2248146-1998-00548
    Event Type
    Malfunction
    Date Received
    May 14, 1998
    Date of Event
    May 3, 1998
    Report Date
    May 12, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 07/08/1998). EVALUATION: LABORATORY EXAMINATION OF THE RETURNED ITEM REVEALED NO DEFECT. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. TESTING FOR OCCULT BLOOD WITHIN THE BALLOON WAS NEGATIVE. THE IAB INFLATED AND FUNCTIONED NORMALLY WHEN ATTACHED TO THE SYSTEM 97 IABP IN THE LAB. NO ALARMS WERE TRIGGERED. PROBABLE CAUSE OF DIFFICULTY: NO LEAK WAS FOUND IN THE RETURNED IAB. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED DIFFICULTY BASED ON THE EVENT DESCRIPTION AND EXAMINATION OF THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    THE IAB LEAKED BACK INTO THE PUMP. ON 06/10/1998, IT WAS REPORTED THAT BLOOD WAS NOTED IN THE GAS LINE. THE PUMP WAS TURNED OFF AND THE CARDIOLOGIST WAS NOTIFIED. THE IAB WAS REMOVED. THERE WAS NOT PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PT WAS FINE AFTER THE EVENT. THE PT WENT HOME. (EVENT COMPLICATIONS): UNK - REPORTED 05/12/1998; NONE - REPORTED 06/10/1998. (PT CURRENT STATUS): HOME - REPORTED 06/10/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0321 04/16/00

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR