BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GP SERIES INFUSION SET

    MDR report key: 10645792 · Received October 7, 2020

    Report

    Report Number
    9616066-2020-20019
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    June 26, 2020
    Report Date
    November 2, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K011120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LISTED IS NOT A FINISHED MEDICAL DEVICE BY BD AND THEREFORE SHOULD NOT HAVE BEEN REPORTED. MFR# 9616066-2020-20019 IS CANCELLED AND VOID AS A RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GP SERIES INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFUSION WAS RUNNING FOR APPROX. 20 MINUTES UNTIL FIRST FLOW ERROR ALARM APPEARED. NURSE CHECKED PUMP AND SET AND RESTARTED THE PUMP. WITHIN 5 MIN PUMP ALARMED AGAIN. THIS TIME IT WAS AN UPSTREAM OCCLUSION ALARM. NURSE CHECKED AGAIN SET, NO ERROR DETECTED. NURSE STARTED PUMP AGAIN. AFTER 5 MIN NEXT FLOW ERROR ALARM APPEARED. EVEN AFTER CHANGING THE SET THESE TWO ALARMS APPEARED APPROX. EVERY 5 MIN. BIOMED TESTED THE PUMP TOO, WITH THE SAME ISSUES. INSTALLATION DATE OF PUMP WAS 03.06.2020. PUMP AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 1014223. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GP SERIES INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFUSION WAS RUNNING FOR APPROX. 20 MINUTES UNTIL FIRST FLOW ERROR ALARM APPEARED. NURSE CHECKED PUMP AND SET AND RESTARTED THE PUMP. WITHIN 5 MIN PUMP ALARMED AGAIN. THIS TIME IT WAS AN UPSTREAM OCCLUSION ALARM. NURSE CHECKED AGAIN SET, NO ERROR DETECTED. NURSE STARTED PUMP AGAIN. AFTER 5 MIN NEXT FLOW ERROR ALARM APPEARED. EVEN AFTER CHANGING THE SET THESE TWO ALARMS APPEARED APPROX. EVERY 5 MIN. BIOMED TESTED THE PUMP TOO, WITH THE SAME ISSUES. INSTALLATION DATE OF PUMP WAS (B)(6) 2020. PUMP AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111267 GP SERIES INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1014223

    Patients

    Seq Age Sex Outcome Treatment
    1 Other