BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 159383 · Received March 23, 1998

    Report

    Report Number
    2248146-1998-00304
    Event Type
    Malfunction
    Date Received
    March 23, 1998
    Date of Event
    March 10, 1998
    Report Date
    March 11, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE IAB WAS REC'D INTACT FOR EVAL WITH THE BALLOON COMPLETELY UNFOLDED. AS A TEST, THE IAB WAS PLACED IN A TEST CHAMBER HAVING A 75 MMHG BACK PRESSURE TO SIMULATE THE PRESSURE WITHIN THE AORTA. THE BALLOON FULLY INFLATED AND FUNCTIONED NORMALLY WHEN ATTACHED TO THE SYS 97 IABP IN THE LAB. NO ALARMS WERE TRIGGERED ON THE PUMP. AFTER 2 MINS OF PUMPING, AN INFLATION/DEFLATION CHART WAS RECORDED. THE CHART CONFIRMED THAT THE BALLOON FULLY INFLATED AND DEFLATED SATISFACTORILY AT 100 AND 140 BPM DURING IABP TESTING. THUS, LAB EXAMINATION REVEALED NO DEFECTS IN THE RETURNED IAB. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 5/01/98).

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 3/9/98 AT 1:30 PM AND REMOVED ON 3/10/98 AT 3:40 PM. THE PT WAS TRANSFERRED FROM ANOTHER FACILITY. THE NURSE CARING FOR THE PT STATED THE PT SAT UP AND A KINK WAS NOTED IN THE IAB. THE CENTRAL LUMEN LINE WAS KINKED AS WELL AND CLOTTED. ALSO, THERE WAS POOR INFLATION AND AUGMENTATION. (ON 3/30/98, DATASCOPE REC'D THE VOLUNTARY MEDWATCH FORM FROM THE FDA; MDR ACCESS NUMBER: 1013206). [EVENT COMPLICATIONS]: NONE FROM THE EVENT-REPORTED 3/11/98. [PT'S CURRENT STATUS]: UNK-3/11/98.

    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 9/13/99

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR