BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 173793 · Received June 19, 1998

    Report

    Report Number
    2248146-1998-00671
    Event Type
    Malfunction
    Date Received
    June 19, 1998
    Report Date
    June 9, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE IAB WAS RECIEVED INTACT FOR EVALUATION WITH THE BALLOON COMPLETELY UNFOLDED. THE CATHETER AND INNER LUMEN WERE NOTED TO BE KINKED. BLOOD WAS NOTED ON THE EXTERIOR OF THE MEMBRANE AQND WITHIN THE INNER LUMEN. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. THE IAB PUMPED SATISFACTORILY ON THE LABORATORY SYSTEM 97 AT 100 AND 140 BPM. NO ALARMS WERE TRIGGERED. PROBABLE CAUSE OF DIFFICULTY: NO LEAK WAS FOUND IN THE IAB TO HAVE CAUSED THE REPORTED EXCESSIVE PUMP ALARMS. IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED DIFFICULTY BASED ON THE EVENT DESCRIPTION AND EXAMINATION. IN GENERAL, EXCESSIVE ALARMS MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: A TEMPORARY KINK IN THE CATHETER TUBING MAY HAVE PREVENTED THE FLOW OF HELIUM INTO AND OUT OF THE BALLOON MEMBRANE CAUSING THE PUMP TO SENSE A "LOSS" OF GAS OR TO DISPLAY "CATHETER FAULT". MANIPULATION OF THE BALLOON CATHETER MAY HAVE ALLEVIATED THE PROBLEM. (THE CATHETER TUBING MAY HAVE BECOME KINKED IF THE IAB WAS NOT REMOVED FROM THE TRAY RETAINERS ACCORDING TO DATASCOPE'S INSTRUCTIONS FOR USE.) THERE WAS A LOOSE CONNECTION BETWEEN THE IAB AND THE PUMP OR BETWEEN THE PUMP AND THE SAFETY CHAMBER. CHECKING THESE CONNECTIONS MAY HAVE ALLEVIATED THE PROBLEM THE PUMP MAY HAVE NEEDED SERVICING. THE PUMP MAY HAVE DETECTED CONDENSATION OR BLOOD WITHIN THE LINE (PERHAPS FROM A PREVIOUS BALLOON LEAK).

    Description of Event or Problem · 1

    EVENT: (CC# 98-00706) THE "SYSTEM LEAK" ALARM SOUNDED FROM THE PUMP AND THE IAB WOULD NOT INFLATE. ON 2/9/99, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE BALLOON NEVER INFLATED PROPERLY BECAUSE THE SYSTEM KEPT INDICATING THAT THERE WAS A LEAK. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 6/9/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 6/9/98.

    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. 0684-00-0283 04/20/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN