BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20DP CKV 3SS DEHP FREE

    MDR report key: 11794836 · Received May 7, 2021

    Report

    Report Number
    9616066-2021-50934
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 26, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO PHOTOS OF A PRIMARY SET, MODEL 2426-0007, WAS RECEIVED BY THE CUSTOMER FOR INVESTIGATION. UPON VISUAL INSPECTION, IT COULD BE OBSERVED THAT THE SET'S UPPER FITMENT WAS DISCONNECTED FROM THE SILICON PUMPING SEGMENT. NO OTHER DEFECTS WERE OBSERVED. THE CUSTOMER'S COMPLAINT THAT TUBING SPONTANEOUSLY DISCONNECTED WAS VERIFIED. HOWEVER, SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2426-0007 LOT NUMBER 20086901 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 24AUG2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2426-0007 BATCH/ LOT #: 20086901. WE HAVE HAD INCIDENTS WITH FAULTY TUBING FROM BD ALARIS PUMP INFUSION SETS. IN BOTH CASES, THE TUBING SPONTANEOUSLY DISCONNECTED WHEN THE NURSE REMOVED THE TUBING FROM THE PUMP. SHE DID NOT PULL, YANK, OR REMOVE THE TUBING FROM THE PUMP CHAMBER WITH EXCESSIVE FORCE. NO INJURIES OR HARM WAS CAUSED, AS NO HAZARDOUS DRUGS WERE ATTACHED TO THE TUBING.

    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 GEM 20DP CKV 3SS DEHP FREE EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2426-0007 BATCH/ LOT #: 20086901. WE HAVE HAD INCIDENTS WITH FAULTY TUBING FROM BD ALARIS PUMP INFUSION SETS. IN BOTH CASES, THE TUBING SPONTANEOUSLY DISCONNECTED WHEN THE NURSE REMOVED THE TUBING FROM THE PUMP. SHE DID NOT PULL, YANK, OR REMOVE THE TUBING FROM THE PUMP CHAMBER WITH EXCESSIVE FORCE. NO INJURIES OR HARM WAS CAUSED, AS NO HAZARDOUS DRUGS WERE ATTACHED TO THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687136 GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20086901

    Patients

    Seq Age Sex Outcome Treatment
    1