BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 10040867 · Received May 8, 2020

    Report

    Report Number
    9616066-2020-01538
    Event Type
    Malfunction
    Date Received
    May 8, 2020
    Report Date
    April 16, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE SPECIFIC LOT NUMBER FOR THE EVENT SET WAS NOT IDENTIFIED, THE CUSTOMER REPORTED THE FOLLOWING LOTS WERE IN STOCK AT THE TIME. THE DEVICE HISTORY RECORDS ARE PROVIDED BELOW. DEVICE HISTORY RECORD FOR MODEL 2420-0007 LOT 20013388 SHOWS THAT THE SET WAS MANUFACTURED ON (B)(6) 2020 WITH A TOTAL OF 34,563 UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. DEVICE HISTORY RECORD FOR MODEL 2420-0007 LOT 19086359 SHOWS THAT THE SET WAS MANUFACTURED ON (B)(6) 2019 WITH A TOTAL OF 17,283 UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. DEVICE HISTORY RECORD FOR MODEL 2420-0007 LOT 20013387 SHOWS THAT THE SET WAS MANUFACTURED ON (B)(6) 2020 WITH A TOTAL OF 34,563 UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. DEVICE HISTORY RECORD FOR MODEL 2420-0007 LOT 19023154 SHOWS THAT THE SET WAS MANUFACTURED ON (B)(6) 2019 WITH A TOTAL OF 23,043 UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. DEVICE HISTORY RECORD FOR MODEL 2420-0007 LOT 20015801 SHOWS THAT THE SET WAS MANUFACTURED ON(B)(6) 2020 WITH A TOTAL OF 17,283 UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. DEVICE HISTORY RECORD FOR MODEL 2420-0007 LOT 18083129 SHOWS THAT THE SET WAS MANUFACTURED ON (B)(6) 2018 WITH A TOTAL OF 23,043 UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. DEVICE HISTORY RECORD FOR MODEL 2420-0007 LOT 20026573 SHOWS THAT THE SET WAS MANUFACTURED ON (B)(6) 2020 WITH A TOTAL OF 34,563 UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. DEVICE HISTORY RECORD FOR MODEL 2420-0007 LOT 20015821 SHOWS THAT THE SET WAS MANUFACTURED ON (B)(6) 2020 WITH A TOTAL OF 34,563 UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING SET LEAKED DURING A HEPARIN INFUSION THAT WAS INITIATED AT 11:01. AT APPROXIMATELY 16:15, THE RN FOUND FLUID ON THE FLOOR WITH THE HEPARIN INFUSION FREE FLOWING DESPITE THAT THE DEVICE SETTINGS WERE CORRECT. FURTHER ASSESSMENT FOUND THAT THERE WAS A SMALL HOLE NOTED IN THE SILICONE SEGMENT.

    Additional Manufacturer Narrative · 1

    UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING SET LEAKED DURING A HEPARIN INFUSION THAT WAS INITIATED AT 11:01. AT APPROXIMATELY 16:15, THE RN FOUND FLUID ON THE FLOOR WITH THE HEPARIN INFUSION FREE FLOWING DESPITE THAT THE DEVICE SETTINGS WERE CORRECT. FURTHER ASSESSMENT FOUND THAT THERE WAS A SMALL HOLE NOTED IN THE SILICONE SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501678 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 8100,8015, THERAPY DATE UNKNOWN