BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNSPECIFIED BD ALARIS PUMP SET

    MDR report key: 11666746 · Received April 14, 2021

    Report

    Report Number
    2243072-2021-01110
    Event Type
    Death
    Date Received
    April 14, 2021
    Date of Event
    March 16, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT WAS RAISED DUE TO THE CUSTOMER INDICATING THAT THERE WAS A CLINICAL EVENT WHICH HAD LED TO THE DEATH OF A CHILD IN A NEONATAL WARD, AND THEY SUSPECTED THAT IT MIGHT BE LINKED TO THE RECENT FIELD SAFETY CORRECTIVE ACTION (FSCA) - MDS-21-4072. NO SAMPLES OR FURTHER DETAILS WERE AVAILABLE RELATING TO THE PATIENT INCIDENT IN (B)(4), HOWEVER THE CUSTOMER LATER RESPONDED TO SAY THAT THEY HAD INVESTIGATED THE ISSUE INTERNALLY AND CONCLUDED THAT THERE WAS NO LONGER ANY GROUND FOR SUSPICION OF THE BD PRODUCTS. THIS COMPLAINT HAS BEEN LINKED TO MDS-21-4072-SA, HOWEVER THERE WAS NO EVIDENCE THAT THIS WAS COMPLAINT WAS LINKED TO THE STERILIZATION ISSUE. CAPA NUMBER: PR 2539081 BD ARE PERFORMING A FSCA BASED ON A NOTIFICATION FROM A 3RD PARTY STERILISATION PROVIDER THAT THEY HAD INTENTIONALLY FALSIFIED STERILISATION PROCESS RECORDS. ALTHOUGH BD ARE TAKEN THIS ACTION, PLEASE NOTE THAT THERE HAVE BEEN NO CONFIRMED COMPLAINTS RELATING TO THE STERILITY OF THE PRODUCTS INCLUDED IN THE FSN TO-DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD ALARIS¿ PUMP SET HAD "FSN" FOUND IN IT DUE TO STERILITY ISSUES, WHICH WAS CONNECTED TO A NEONATAL PATIENT'S DEATH. NO FURTHER INFORMATION HAS BEEN PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUE TO FSN ON ALARIS SETS, THEY HAVE A SUSPICION REGARDING LACK OF STERILIZATION OF ALARIS SETS TO BE THE REASON OF THE DEATH OF A CHILD AT NEONATAL WARD. THEY ARE LOOKING INTO THIS SUSPICION TO SEE IF IT COULD BE DUE TO LACK OF STERILIZATION. THEY WILL GET BACK TO US WITH ALL DOCUMENTATION IF THERE IS MORE FOUNDATION FOR THE SUSPICION. IT HAS NOT BEEN POSSIBLE TO GET ANY MORE INFORMATION OR CONTACTS SO FAR.

    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. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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¿ PUMP SET HAD "FSN" FOUND IN IT DUE TO STERILITY ISSUES, WHICH WAS CONNECTED TO A NEONATAL PATIENT'S DEATH. NO FURTHER INFORMATION HAS BEEN PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUE TO FSN ON ALARIS SETS, THEY HAVE A SUSPICION REGARDING LACK OF STERILIZATION OF ALARIS SETS TO BE THE REASON OF THE DEATH OF A CHILD AT NEONATAL WARD. THEY ARE LOOKING INTO THIS SUSPICION TO SEE IF IT COULD BE DUE TO LACK OF STERILIZATION. THEY WILL GET BACK TO US WITH ALL DOCUMENTATION IF THERE IS MORE FOUNDATION FOR THE SUSPICION. IT HAS NOT BEEN POSSIBLE TO GET ANY MORE INFORMATION OR CONTACTS SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562496 UNSPECIFIED BD ALARIS PUMP SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other