BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 188229 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01038
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Date of Event
    August 21, 1998
    Report Date
    September 3, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01113) THE "BLOOD DETECTED" ALARM SOUNDED FROM THE PUMP. NO BLOOD WAS NOTED AND THE PUMP WAS CHANGED. THE SAME ALARM SOUNDED ON THIS PUMP AND THE IAB LEAKED. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01112) THE FOLLOWING WAS REPORTED TO DATASCOPE ON 9/24/98: THE PUMP WAS ALARMING. THE PUMP SOUNDED "BLOOD DETECTED" BUT NO VISIBLE BLOOD WAS NOTED IN THE TUBING. THE PUMP WAS CHANGED BUT THE ALARMS CONTINUED. THE DOCTOR WAS NOTIFIED. THE DOCTOR TOOK THE PATIENT TO THE CATH LAB AT WHICH TIME IT WAS DISCOVERED THAT THE BALLOON HAD LEAKED. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER INTERVENTION. (ON 9/24/98, DATASCOPE RECEIVED THE MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT NUMBER: 14-0258-1998-0155) [EVENT COMPLICATIONS]: TRANSFERRED-RPT'D 9/3/98 AND 9/24/98. [PATIENT'S CURRENT STATUS]: TRANSFERRED-RPT'D 9/3/98.

    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 06/18/00

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR