BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 169704 · Received May 22, 1998

    Report

    Report Number
    2248146-1998-00579
    Event Type
    Malfunction
    Date Received
    May 22, 1998
    Date of Event
    May 19, 1998
    Report Date
    May 19, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 07/08/1998). EVALUATION: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITHSH 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 PRODUCED BY CALCIFIED PLAQUE DURING IABP.

    Description of Event or Problem · 1

    THE IAB LEAKED & THE IAB WAS REMOVED. A SECOND IAB WAS INSERTED INTO THE PT. ON 06/10/1998, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE IABP BEGAN ALARMING "CHECK IAB CATHETER". THE NURSE BEGAN TROUBLESHOOTING (CHECKING FOR KINKS). DARK FLECKS WERE NOTED IN THE TUBING AND IABP WAS STOPPED. THE CATHETER WAS REMOVED & ANOTHER WAS INSERTED INTO THE PT. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PT IS ALIVE & REMAINS INTUBATED. (EVENT COMPLICATIONS): UNK - REPORTED 05/19/1998; NONE REPORTED 06/10/1998 & 06/17/1998. (PT'S CURRENT STATUS): INTUBATED - REPORTED 06/10/1998.

    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 CORP. 0684-00-0306 05/01/00

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR