BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOW DETECTOR

    MDR report key: 104897 · Received July 11, 1997

    Report

    Report Number
    2921482-1997-00122
    Event Type
    Injury
    Date Received
    July 11, 1997
    Date of Event
    June 4, 1997
    Report Date
    June 4, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FLN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION CONFIRMED FREE FLOW WITH A RETURNED SET. THE RETURNED UNUSED SET TESTED OK. THE FLOW DETECTOR TESTED OK. THE PUMP WAS RECEIVED WITH LOOSE BOARDS, HOWEVER, WHEN TESTED WITH A NEW SET THE UNIT PASSED ALL PERFORMANCE VERIFICATION AND LONG TERM TESTS WITHIN PRODUCT SPECIFICATION. A DEFECTIVE ADMINISTRATION SET CAUSED THE FREE FLOW.

    Description of Event or Problem · 1

    REPORT OF "FREE FLOW' OF NITROGLYCERIN RECEIVED. THE PUMP WAS BEING SET UP IN THE EMERGENCY DEPARTMENT TO ADMINISTER A NITROGLYCERIN INFUSION AT 3 ML/HR. AT INITIAL SETUP, A NURSE IMMEDIATELY NOTED A FAST FLOW OF FLUID IN THE DRIP CHAMBER. SHE STOPPED THE FLOW, TURNED THE DEVICE OFF/ON, RESET IT FOR 3 ML/HR AND RESTARTED THE INFUSION. THE SAME SCENARIO OCCURRED. THE DEVICE DID NOT ALARM, BUT THE NURSE REPORTED SHE IMMEDIATELY INTERVENED AND MAY NOT HAVE GIVEN THE PUMP TIME TO ALARM. THE PT EXPERIENCED A DROP IN BLOOD PRESSURE FROM A BASELINE OF 120-140/70 TO 66/30. SHE WAS PLACED IN THE TRENDELENBERG POSITION AND HER BLOOD PRESSURE QUICKLY RETURNED TO BASELINE. THE PUMP WAS SWITCHED OUT AND THE SAME TUBING WORKED FINE IN THE NEW DEVICE. THE PT WAS THEN TRANSFERRED TO THE ICU. UPON ARRIVAL IN THE ICU, THE DEVICE WAS ALARMING FOR "FLOW." THE ICU NURSE NOTED THAT THE NITROGLYCERIN WAS FLOWING TOO FAST. THE PT REPORTEDLY HAD ANOTHER TRANSIENT DROP IN BLOOD PRESSURE, BUT QUICKLY RECOVERED AFTER THE INFUSION WAS STOPPED. THE TUBING WAS SWITCHED OUT, AND THE NEW SET WAS THEN USED SUCCESSFULLY WITH THE SECOND PUMP THAT WAS INITIATED IN THE ER. THERE WERE NO ADVERSE SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW DETECTOR DROP DETECTOR FLN ABBOTT LABORATORIES NA 68-707-G1

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention LIST 01813, REPORTED| LOT 16-081-NS, REPORTED| LIFECARE MODEL 3 INFUSION PUMP| NITROGLYCERIN PUMP TUBING, LIST 01772