BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PUMP SET

    MDR report key: 11678213 · Received April 16, 2021

    Report

    Report Number
    2243072-2021-01175
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 9, 2021
    Report Date
    May 17, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: CATALOG # 2426-0500. UDI # (B)(4). PMA / 510(K)#: K944320. INVESTIGATION SUMMARY NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THE CLINICIAN NOTICED FLUID BACKING UP FROM ONE TUBING DRIP CHAMBER TO ANOTHER. THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2426-0500 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NORMAL SALINE BACKED UP FROM THE UNSPECIFIED BD¿ PUMP SET TUBING DRIP CHAMBER INTO THE SECONDARY LINE CHAMBER AT THE END OF THE GEMCITABINE INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CHEMOTHERAPY/IMMUNOTHERAPY GIVEN: 0.9% SODIUM CHLORIDE 250 ML ATTACHED TO PRIMARY TUBING PRODUCT #07613203020992 WAS HUNG AS LINE FLUSH BAG ON A SECONDARY HANGER SO LEVEL WAS BELOW PRIMARY CHEMO BAG. PACLITAXEL/ALBUMIN-BOUND CAME ATTACHED TO A SECONDARY LINE PRE-PRIMED FROM PHARMACY. INFUSED FIRST; COMPLETED W/O DIFFICULTY. GEMCITABINE 1344 MG IN NS 250 ML CAME ATTACHED WITH A PRE-PRIMED SECONDARY LINE FROM PHARMACY : EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE SECONDARY TUBING PRODUCT NUMBER #07290013484413 AT THE END OF THE INFUSION OF THE GEMCITABINE, WHEN THE NS FLUSH SHOULD HAVE STARTED, IT WAS NOTED THAT THE NS HAD BACKED UP INTO THE CHAMBER OF THE SECONDARY LINE (ATTACHED TO GEMCITABINE) WHICH HAD BEEN EMPTY. IT WAS ALSO NOTED THAT BOTH OF THE LINES WERE DRIPPING SIMULTANEOUSLY. TO RESOLVE THE ISSUE, THE NURSE PINCHED THE NS LINE TO ALLOW THE GEMCITABINE SECONDARY LINE TO EMPTY AGAIN. THEN WE CLAMPED THAT LINE AND ALLOWED THE FLUSH TO RESUME."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NORMAL SALINE BACKED UP FROM THE UNSPECIFIED BD¿ PUMP SET TUBING DRIP CHAMBER INTO THE SECONDARY LINE CHAMBER AT THE END OF THE GEMCITABINE INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CHEMOTHERAPY/IMMUNOTHERAPY GIVEN: 0.9% SODIUM CHLORIDE 250 ML ATTACHED TO PRIMARY TUBING PRODUCT #07613203020992 WAS HUNG AS LINE FLUSH BAG ON A SECONDARY HANGER SO LEVEL WAS BELOW PRIMARY CHEMO BAG. PACLITAXEL/ALBUMIN-BOUND CAME ATTACHED TO A SECONDARY LINE PRE-PRIMED FROM PHARMACY. INFUSED FIRST; COMPLETED W/O DIFFICULTY. GEMCITABINE 1344 MG IN NS 250 ML CAME ATTACHED WITH A PRE-PRIMED SECONDARY LINE FROM PHARMACY : EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE SECONDARY TUBING PRODUCT NUMBER #07290013484413. AT THE END OF THE INFUSION OF THE GEMCITABINE, WHEN THE NS FLUSH SHOULD HAVE STARTED, IT WAS NOTED THAT THE NS HAD BACKED UP INTO THE CHAMBER OF THE SECONDARY LINE (ATTACHED TO GEMCITABINE) WHICH HAD BEEN EMPTY. IT WAS ALSO NOTED THAT BOTH OF THE LINES WERE DRIPPING SIMULTANEOUSLY. TO RESOLVE THE ISSUE, THE NURSE PINCHED THE NS LINE TO ALLOW THE GEMCITABINE SECONDARY LINE TO EMPTY AGAIN. THEN WE CLAMPED THAT LINE AND ALLOWED THE FLUSH TO RESUME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573884 UNSPECIFIED BD PUMP SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1