BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 10382684 · Received August 7, 2020

    Report

    Report Number
    9616066-2020-02457
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 16, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    07613203020992
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF LEAKAGE WAS RECEIVED FROM THE CUSTOMER. DUE TO NO SAMPLE BEING SENT THE COMPLAINT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2426-0500 LOT NUMBER 20043192 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 14APR2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED LEAKAGE AND COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RESPONSE (B)(6)-2020: THERE WERE NO ADVERSE EVENT(S) REPORTED. CAT# 2426-0500 ITEM# 212255 QTY 1 EA DESCRIPTION: SET IV ADMIN 20 GTT VLV 126 LF W CHECK 3 PORT DEHP AFTER PRIMING IV TUBING AND TRANSPORTING FLUSH BAG TO PATIENT INFUSION CHAIR, NOTED PUMP TUBING BECAME DISCONNECTED FROM TUBING DRIP CHAMBER, RESULTING IN LARGE AMOUNT OF FLUID BEING SPILLED ONTO FLOOR; THIS COULD'VE BEEN A MUCH WORSE SITUATION AND A COSTLY MISHAP IF THE BAG WOULD'VE CONTAINED CHEMOTHERAPY OR IMMUNOTHERAPY. WAS THERE HARM? -NO NO ABNORMAL MANIPULATION, SEVERING , OR PINCHING OF TUBING DURING THE PRIMING OR TRANSPORTING OF THE FLUSH BAG FROM THE MED ROOM TO THE INFUSION ROOM. TUBING SIMPLY BECAME DISCONNECTED RESULTING IN RAPID LOSS OF IVF TO THE FLOOR. TUBING LOT NUMBER (10)20043192; REF 2426-0500 BD ALARIS PUMP INFUSION SET. EVENT DATE (MM/DD/YYY) (B)(6) 2020 IS THE EVENT TIME KNOWN? YES EVENT TIME (HH:MM) 10:30

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED LEAKAGE AND COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RESPONSE (B)(6) 2020: THERE WERE NO ADVERSE EVENT(S) REPORTED. CAT# 2426-0500 ITEM# 212255 QTY 1 EA DESCRIPTION: SET IV ADMIN 20 GTT VLV 126 LF W CHECK 3 PORT DEHP AFTER PRIMING IV TUBING AND TRANSPORTING FLUSH BAG TO PATIENT INFUSION CHAIR, NOTED PUMP TUBING BECAME DISCONNECTED FROM TUBING DRIP CHAMBER, RESULTING IN LARGE AMOUNT OF FLUID BEING SPILLED ONTO FLOOR; THIS COULD'VE BEEN A MUCH WORSE SITUATION AND A COSTLY MISHAP IF THE BAG WOULD'VE CONTAINED CHEMOTHERAPY OR IMMUNOTHERAPY. WAS THERE HARM? NO. NO ABNORMAL MANIPULATION, SEVERING , OR PINCHING OF TUBING DURING THE PRIMING OR TRANSPORTING OF THE FLUSH BAG FROM THE MED ROOM TO THE INFUSION ROOM. TUBING SIMPLY BECAME DISCONNECTED RESULTING IN RAPID LOSS OF IVF TO THE FLOOR. TUBING LOT NUMBER (10)20043192; REF 2426-0500 BD ALARIS PUMP INFUSION SET. EVENT DATE (MM/DD/YYYY) (B)(6) 2020. IS THE EVENT TIME KNOWN? YES. EVENT TIME (HH:MM) 10:30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846820 ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20043192 07613203020992

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200617| 20200617