BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE INFUSION PUMP

    MDR report key: 6184343 · Received December 18, 2016

    Report

    Report Number
    3010293992-2016-00287
    Event Type
    Malfunction
    Date Received
    December 18, 2016
    Report Date
    December 11, 2016
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR INFORMATION: HOSPIRA INC. US SERVICE CENTER, (B)(4), 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 USA: "THE PUMP GIVES ACCIDENTAL BOLUS DOSES OF NARCOTICS WITHOUT PRESSING THE BOLUS BUTTON - CLIENT'S PATIENT RECEIVED ACCIDENTAL BOLUS DOSES OF NARCOTICS FROM THE SAPPHIRE PUMP. PATIENT CLAIMED THAT SHE DID NOT PRESS THE BOLUS BUTTON LOCATED ON THE DEVICE BUT IS GETTING BOLUSES WHEN SHE DID NOT PRESS THE BUTTON. PATIENT INVOLVEMENT: YES. DEATH/SERIOUS INJURY: NO. HUMAN HARM: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835275 SAPPHIRE INFUSION PUMP INFUSION PUMP FRN Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown