BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PLASTIPAK SYRINGES

    MDR report key: 3010957 · Received March 15, 2013

    Report

    Report Number
    2243072-2013-00007
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN RECEIVED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. IF A SAMPLE ARRIVES FOR INVESTIGATION A SUPPLEMENTAL WILL BE COMPLETED AND POTENTIAL ROOT CAUSE WILL BE DETERMINED. THIS IS 5 OF 5 RELATED INCIDENTS FOLLOWING REPORT NUMBERS: 2243072-2013-00003, 2243072-2013-00004, 2243072-2013-00005, 2243072-2013-00006.

    Description of Event or Problem · 1

    INFUSION PUMP CONSTANTLY ALARMING HIGH PRESSURE. HIGH DOSE INOTROPES INFUSION AT TIME. INFUSION PUMP SUBSEQUENTLY CHANGED THEN AFTER A PERIOD OF A FEW MINS PROBLEM RE-OCCURRED. CENTRAL LINE CHECKED FOR KINKS ETC. INOTROPES MOVED TO DIFFERENT LUMEN. MICROCLAVE CONNECTORS REMOVED. FOLLOWING THESE MEASURES DID NOT RESOLVE ISSUE THEREFORE PRESSURE SETTING ON PUMP INCREASED TO NUMBER 9 (MAXIMUM) WHICH EVENTUALLY RESOLVED PROBLEM. PT HAD TO BE BOLUSED WITH ADRENALINE MINI JETS DURING THIS EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110461 BD PLASTIPAK SYRINGES HYPODERMIC SYNRIGE FMF BECTON DICKINSON 1210229

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention