BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE INFUSION PUMP- ENGLISH

    MDR report key: 6098276 · Received November 13, 2016

    Report

    Report Number
    3010293992-2016-00254
    Event Type
    Malfunction
    Date Received
    November 13, 2016
    Date of Event
    January 13, 2014
    Report Date
    November 13, 2016
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (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 (B)(6): "PCA PUMP GIVING EXTRA BOLUS. UNFORTUNATELY WE DID NOT LOG THE NUMBER OF KEY PRESSES BUT IT WOULD HAVE BEEN IN EXCESS OF 12. SUBSEQUENT BOLUS DELIVERIES APPEARED TO THEN BE HAPPENING RANDOMLY WITH NO INPUT FROM ANYBODY AT LEAST 4 OF THESE DELIVERIES WERE OBSERVED. THE DELIVERY TIME BETWEEN THESE RANDOM BOLUS DELIVERIES WAS GREATER THAN THE 5MIN LOCKOUT PERIOD PROGRAMMED. BOLUS CORD AND PUMP WERE IN USE BOTH DURING TESTING AND DURING THE INITIAL PATIENT INCIDENT. FROM MY MEMORY OF THE CONVERSATION WITH THE CUSTOMER THE PATIENT WAS NOT HARMED. PATIENT INVOLVEMENT: YES, DEATH OR SERIOUS INJURY: NO, HUMAN HARM: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749461 SAPPHIRE INFUSION PUMP- ENGLISH INFUSION PUMP FRN Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown