BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 144606 · Received January 15, 1998

    Report

    Report Number
    2248146-1998-00016
    Event Type
    Malfunction
    Date Received
    January 15, 1998
    Date of Event
    January 4, 1998
    Report Date
    January 8, 1998
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCTED BY CALCIFIED PLAQUE DURING IABP.

    Description of Event or Problem · 1

    THE IAB WS INSERTED INTO THE PT ON 1/2/98. ON 1/4/98, THE IAB LEAKED AND THE IAB WAS REMOVED. ANOTHER IAB WAS NOT INSERTED. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-00015) ON 3/2/98, THE FOLLOWING WAS REPORTED TO DATASOPE: THE PUMP ALARMED "RAPID GAS LEAK". BLOOD WAS THEN NOTED IN THE PVC TUBING. PUMPING WAS DISCONTINUED AND SPORADIC ALARMS SOUNDED FROM INSERTION TO THE END OF THERAPY. THERE WAS NO REPORTED PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PT WAS DISCHARGED FROM THE HOSP AND WENT HOME. [EVENT COMPLICATIONS]: NONE FROM THE EVENT-REPORTED 1/8/98 AND 3/2/98. [PT'S CURRENT STATUS]: HOME-RPT'D 3/2/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-0269 12/14/99

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR