BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBIT PUMP CASSETTE

    MDR report key: 823212 · Received February 28, 2007

    Report

    Report Number
    1722214-2007-00012
    Event Type
    Injury
    Date Received
    February 28, 2007
    Date of Event
    January 26, 2007
    Report Date
    January 29, 2007
    Manufacturer
    SORENSON MEDICAL, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL TESTING OF SIMILAR AMBIT CASSETTES INDICATED THAT IF THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED AND THE CASSETTE BOTTOM WAS NOT COMPLETELY SNAPPED INTO PLACE, AN OVER INFUSION MAY OCCUR.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THE SYSTEM WAS USED ON A FEMALE PT FOR MORPHIN-THERAPY REASONS. THE PUMP WAS PROGRAMMED AS FOLLOWED: BASAL FLOW RATE: 0 ML, BOLUS DOSE VOLUME: 0,5 MG; BOLUS LOCKOUT TIME: 10 MIN. DURING A LATER CHECK, IT WAS NOTICED THAT THE WHOLE VOLUME OF THE MEDICATION WAS APPLIED. THE PT WAS DROWSY BUT IT WAS POSSIBLE TO WAKE HER UP WITH TOUCH. BECAUSE OF THE OVERDOSE, AN ANTIDOT WAS IMMEDIATELY APPLIED. THE PT BECAME ACCESSIBLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIT PUMP CASSETTE AMBULATORY INFUSION PUMP CASSETTE FRN SORENSON MEDICAL, INC. NA 611073

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention LOT # 406033| AMBIT PCA PUMP CATALOG# 220262