BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD ALARIS INFUSION SET

    MDR report key: 11901551 · Received May 28, 2021

    Report

    Report Number
    2243072-2021-01554
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 29, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: CATALOG # 2420-0007. D4: UDI # (B)(4). D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-06-25. D11: CONCOMITANT MED PROD DATA: MS3500-15 36 IN 15 DROP SECONDARY SET W/HGR 50885403222618 K790582. G.5. PMA / 510(K)#: K944320. H6: INVESTIGATION SUMMARY: ONE PRIMARY TUBING (MODEL #2420-0007) AND ONE SECONDARY TUBING (MODEL #MS3500-15) WERE RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THE SECONDARY VALVE FAILED AND PRIMARY BAG FILLED. THE SAMPLES WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED BY USING A PRIMARY BAG FILLED WITH CLEAR SALINE WHICH WAS THEN USED TO PRIME THE SET. THE SECONDARY SET WAS CONNECTED TO A BAG FILLED WITH A BLUE DYE/WATER MIXTURE, AND THEN CONNECTED TO THE PRIMARY SET. THE SETS WERE SET UP IN A SECONDARY INFUSION CONFIGURATION WITH THE FLUID LEVEL OF THE SECONDARY BAG AT LEAST 9.5 INCHES HIGHER THAN THE PRIMARY BAG FLUID LEVEL, AND ALL OF THE CLAMPS CLOSED. THE SECONDARY SET WAS PRIMED WITH THE SECONDARY ROLLER CLAMP FULLY OPENED. FLUID FLOW WAS CONTROLLED USING THE PRIMARY ROLLER CLAMP. WHEN FLUID WAS ALLOWED TO FLOW FREELY, FLUID WAS FOUND TO BE FLOWING NORMALLY. NO BACK FLOW WAS OBSERVED. THE FAILURE WAS UNABLE TO BE REPLICATED, AND THE COMPLAINT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2420-0007 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL MS3500-15 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. A ROOT CAUSE WAS UNABLE TO BE DETERMINED BECAUSE THE FAILURE WAS UNABLE TO BE REPLICATED. 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 UNSPECIFIED BD ALARIS¿ INFUSION SET CHECK VALVE MALFUNCTIONED WHILE INFUSING CYTARABINE, AND THE SECONDARY LINE BACK-FLOWED INTO THE PRIMARY LINE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "APPROX. 220CC LEFT IN SECONDARY WHEN VALVE FAILED AND PRIMARY BAG FILLED. TUBING TAKEN DOWN, LEFT IN PUMP. PRIMARY HANGING ON FULLY EXTENDED HANGER, SECONDARY ON TOP HOOK OF POLE. NURSE HAD CHECKED CHEMO BEFORE HER BREAK AT 2330 ¿ ALL OK. NURSE NOTED EMPTY SECONDARY BAG AT 0030 ON ROUNDS."

    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 THE UNSPECIFIED BD ALARIS¿ INFUSION SET CHECK VALVE MALFUNCTIONED WHILE INFUSING CYTARABINE, AND THE SECONDARY LINE BACK-FLOWED INTO THE PRIMARY LINE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "APPROX. 220CC LEFT IN SECONDARY WHEN VALVE FAILED AND PRIMARY BAG FILLED. TUBING TAKEN DOWN, LEFT IN PUMP. PRIMARY HANGING ON FULLY EXTENDED HANGER, SECONDARY ON TOP HOOK OF POLE. NURSE HAD CHECKED CHEMO BEFORE HER BREAK AT 2330 ¿ ALL OK. NURSE NOTED EMPTY SECONDARY BAG AT 0030 ON ROUNDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798900 UNSPECIFIED BD ALARIS INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 IN 15 DROP SECONDARY SET W/HGR