BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP - SPANISH

    MDR report key: 6123924 · Received November 23, 2016

    Report

    Report Number
    3010293992-2016-00261
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 24, 2016
    Report Date
    March 30, 2020
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    07290109150109
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    B.6 TIME LINES: LATE SUBMISSION- DISCUSSED WITH THE FDA OVER A PHONE CALL ON THE (B)(6)2020 . G.1 DISTRIBUTOR INFORMATION: ICU MEDICAL, INC. US SERVICE CENTER (B)(4). EXEMPTION NUMBER,(B)(4). E2014005 Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL.

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM COLOMBIA: "THE PUMP PROGRAMMED ITSELF AFTER FINISHING THE PROGRAMED INFUSION- THE REPORTER STATED THAT PATIENT IN ANALGESIC MANAGEMENT WITH HYDROMORPHONE IN MODE ONLY BOLUS, FINISHED THE VOLUME TO INFUSED THAT WAS PROGRAMMED AND THE PUMP PROGRAMMED ITSELF TO 1ML/H. THEY NOTICED THIS DURING A WATCH AND REPROGRAMMED THE PUMP IN TIME AND BECAUSE OF THIS THERE WAS NO PATIENT HARM NEITHER ADVERSE EVENT. THEN, THEY ISOLATED AND REVISED IT ALONG WITH THE HOSPIRA ENGINEER DIEGO ZERATE WHO WAS REVISING PUMP AT THE HOSPITAL AND THEY NOTICED THAT THE PUMP HAD A PREDEFINED PROGRAMMING OF 1ML/H. PATIENT INFORMATION: INITIALS W. J. V. AGE: 51 GENDER: MASCULINE WEIGHT: 70 KGS DIAGNOSIS: AMPUTATION OF THE RIGHT LIMB, INFRACONDILEA. DRUG CONCENTRATION 0.06 MG/ML, ACCESS TYPE: CENTRAL. DID THE PATIENT STATUS CHANGE BECAUSE OF THIS EVENT? NO PATIENT STATUS BEFORE DURING AND AFTER EVENT. WELL STABLE, THE PATIENT WAS DISCHARGED; THE EVENT DID NOT PROLONG THE PATIENT STAY AT THE HOSPITAL. THERE WAS NO DELAY IN THERAPY. PUMP TREATMENT INFORMATION:HYDROMORPHONE ONLY BOLUS 0.4 MG BLOCK 5 MIN MAX, BOLUS 4 HOURS 5.1CC/HR. TYPE OF DRUG:HYDROMORPHONE PATIENT INVOLVEMENT: YES DEATH/SERIOUS INJURY: NO HUMAN HARM: NO DELAY IN THERAPY: NO MEDICAL INTERVENTION NEED: NO".

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "THE PUMP PROGRAMMED ITSELF AFTER FINISHING THE PROGRAMED INFUSION- THE REPORTER STATED THAT PATIENT IN ANALGESIC MANAGEMENT WITH HYDROMORPHONE IN MODE ONLY BOLUS, FINISHED THE VOLUME TO INFUSED THAT WAS PROGRAMMED AND THE PUMP PROGRAMMED ITSELF TO 1ML/H. THEY NOTICED THIS DURING A WATCH AND REPROGRAMMED THE PUMP IN TIME AND BECAUSE OF THIS THERE WAS NO PATIENT HARM NEITHER ADVERSE EVENT. THEN, THEY ISOLATED AND REVISED IT ALONG WITH (B)(6) WHO WAS REVISING PUMP AT THE HOSPITAL AND THEY NOTICED THAT THE PUMP HAD A PREDEFINED PROGRAMMING OF 1ML/H. PATIENT INFORMATION: (B)(6) GENDER: MASCULINE (B)(6). DIAGNOSIS: AMPUTATION OF THE RIGHT LIMB, INFRACONDILEA. DRUG CONCENTRATION 0.06 MG/ML, ACCESS TYPE: CENTRAL. DID THE PATIENT STATUS CHANGE BECAUSE OF THIS EVENT: NO PATIENT STATUS BEFORE DURING AND AFTER EVENT. WELL STABLE, THE PATIENT WAS DISCHARGED; THE EVENT DID NOT PROLONG THE PATIENT STAY AT THE HOSPITAL. THERE WAS NO DELAY IN THERAPY. PUMP TREATMENT INFORMATION: HYDROMORPHONE ONLY BOLUS 0.4 MG BLOCK 5 MIN MAX, BOLUS 4 HOURS 5.1CC/HR. TYPE OF DRUG:HYDROMORPHONE. PATIENT INVOLVEMENT: YES, DEATH/SERIOUS INJURY: NO, HUMAN HARM: NO, DELAY IN THERAPY: NO, MEDICAL INTERVENTION NEED: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777219 SAPPHIRE M.T INFUSION PUMP - SPANISH INFUSION PUMP FRN Q CORE MEDICAL LTD. 07290109150109

    Patients

    Seq Age Sex Outcome Treatment
    1