BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 167155 · Received May 8, 1998

    Report

    Report Number
    2248146-1998-00512
    Event Type
    Malfunction
    Date Received
    May 8, 1998
    Date of Event
    April 27, 1998
    Report Date
    May 5, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVAL. THE ITEM WAS DISCARDED BY THE HOSP. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 7/8/98).

    Description of Event or Problem · 1

    THE IAB LEAKED AND WAS REMOVED. A SECOND IAB WAS INSERTED INTO THE PT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER, 98-00543, 98-00544). THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVAL. THE IAB WAS DISCARDED BY THE FACILITY. ON 6/10/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: A "CHECK IAB CATHETER" ALARM SOUNDED FROM THE PUMP WHILE IN CORONARY CARE UNIT. ALL CONNECTINOS WERE CHECKED AND THE IAB WAS REFILLED AND RESTARTED. THE PUMP ALARMED AGAIN AND BLOOD WAS NOTED IN THE DRIVE LINE. PUMPING WAS STOPPED AND THE CARDIOLOGIST WAS NOTIFIED. THE PT WAS TAKEN TO THE CATH LAB FOR REMOVAL OF THE BALLOON. ANOTHER IAB WAS INSERTED WITHOUT DIFFICULTY. DURING PUMPING, IT WAS DIFFICULT TO ACHIEVE GOOD AUGMENTATION. THE PT WAS IN ARTERIAL FIB WITH ECTOPY. THE PT IS RECOVERING. [EVENT COMPLICATIONS]: UNK-REPORTED 5/5/98 AND 6/10/98. [PT'S CURRENT STATUS]: RECOVERING-RPT'D 6/10/98.

    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 CORP. 0684-00-0321 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR