BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE INFUSION PUMP- ENGLISH

    MDR report key: 6252852 · Received January 15, 2017

    Report

    Report Number
    3010293992-2016-00317
    Event Type
    Malfunction
    Date Received
    January 15, 2017
    Date of Event
    January 2, 2015
    Report Date
    January 12, 2017
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    07290109150109
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPIRA INC. US SERVICE CENTER SAN JOSE, CA 95138 EXEMPTION NUMBER, E2014005 Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HOSPIRA. THIS COMPLAINT WAS NOT DEEMED REPORTABLE UNDER THE THEN EFFECTIVE REPORTING PROCEDURE, BUT IS REPORTABLE UNDER REVISED REPORTING PROCEDURE WHICH EXERCISES STRICTER INTERPRETATION TO REPORTING OBLIGATION. THIS CASE IS AN OUTCOME OF RETROSPECTIVE REVIEW PERFORMED ON ALL OUR OLD NON-REPORTABLE EVENTS, TO ENSURE ALL OUR CASES ARE IN -PART WITH OUR NEW PROCEDURE (OF THE ~920 FILES REVIEWED IN THE RETROSPECTIVE REVIEW 33 CASES WERE DEEMED REPORTABLE BASED ON THE CURRENT REPORTING SCHEME. OF COURSE NONE HAD SERIOUS INJURY OR DEATH, AS THOSE ARE REPORTABLE UNDER OLD AND NEW PROCEDURES).

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6).: "UNDER DELIVERY. PATIENT INVOLVEMENT: YES DEATH/SERIOUS INJURY: NO HUMAN HARM: NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35994 SAPPHIRE INFUSION PUMP- ENGLISH INFUSION PUMP FRN Q CORE MEDICAL LTD. 07290109150109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown