BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR 40 CC IAB

    MDR report key: 161504 · Received April 1, 1998

    Report

    Report Number
    2248146-1998-00385
    Event Type
    Malfunction
    Date Received
    April 1, 1998
    Date of Event
    March 18, 1998
    Report Date
    March 31, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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: THE PUMP HAD ALARMED & IT INDICATED THAT BLOOD WAS IN THE TUBING. THE NURSE CHECKED THE CATHETER & FOUND THAT IT HAD BLOOD IN IT. THE NURSE NOTIFIED THE RESIDENT AND THE IAB WS REMOVED. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PT WAS STABLE AFTER THE EVENT ON 03/18/1998. THE PT REMAINED IN INTENSIVE CARE UNIT WITH A PULMONARY PROBLEM. (EVENT COMPLICATIONS): NONE FROM THE EVENT - REPORTED 03/31/1998 & 05/19/1998. (PT'S CURRENT STATUS): STABLE - 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. 0684-00-0269 11/14/99

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR