BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 155661 · Received March 9, 1998

    Report

    Report Number
    2248146-1998-00246
    Event Type
    Malfunction
    Date Received
    March 9, 1998
    Date of Event
    February 24, 1998
    Report Date
    February 27, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 06/08/1998). EVALUATION: 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 PRODUCED BY CALCIFIED PLAQUE DURING IABP.

    Description of Event or Problem · 1

    ON 05/19/1998, THE FOLLOWING WAS REPORTED TO DATASCOPE: NO AUGMENTATION WAS NOTED ON THE BLOOD PRESSURE TRACE. THE PT'S HEART RATE WAS LESS THAN 120 BEATS PER MINUTE. NO ALARMS SOUNDED FROM THE PUMP OR MESSAGES ON SCREEN. THE PUMP WAS CHANGED BUT THE SAME PROBLEMS OCCURRED. THE PUMP CHECKED OUT OKAY. THE BALLOON WAS REMOVED AND BLOOD WAS OBSERVED INSIDE THE BALLOON, BUT NOT IN THE TUBING. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. AS OF 02/26/1998, THE PT REMAINED VENTILATED IN CORONARY INTENSIVE CARE UNIT. (EVENT COMPLICATIONS): UNKNOWN - REPORTED 02/27/1998.; NONE - REPORTED 05/19/1998. (PT'S CURRENT STATUS): IN CORONARY INTENSIVE CARE UNIT - REPORTED 05/19/1998.

    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 11/24/99

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR