BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE EXTERNAL BATTERY PACK

    MDR report key: 5436105 · Received February 15, 2016

    Report

    Report Number
    3010293992-2016-00040
    Event Type
    Malfunction
    Date Received
    February 15, 2016
    Report Date
    February 25, 2018
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL. EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED FROM A CUSTOMER FROM USA: "AS YOU ARE AWARE, WE HAVE HAD MANY ISSUES WITH THE PUMPS SINCE IMPLEMENTATION. THE PROBLEM WITH THE INFUSION HAS BEEN REPORTED TO THE HOSPIRA PRODUCT COMPLAINT DEPARTMENT PER YOUR INSTRUCTIONS. WE NOW HAVE A PATIENT SAFETY CONCERN BECAUSE WE HAD A BATTERY PACK BECOME SO HOT WITHIN 5 MINUTES THAT IT MELTED THE INSIDE OF THE BOX AND HAD A SMALL AMOUNT OF SMOKE. THE LAST BATTERY IN THE PACK WAS PLACED IN BACKWARDS. WE'LL REPORT THIS THROUGH THE PRODUCT COMPLAINT DEPARTMENT AS WELL. WE CAN DISCUSS THIS ON THE CALL TOMORROW. I WASN'T INCLUDED ON THE INVITATION FOR THIS CALL BUT EDUCATION HAS FORWARDED IT TO ME SO I CAN JOIN. DELAY IN THERAPY: UNKNOWN. NEED FOR MEDICAL INTERVENTION: UNKNOWN. DEATH / SERIOUS INJURY: NO." ADDITIONAL INFORMATION WAS RECEIVED ON JUN.21TH, 2016: "BELOW IS THE REQUESTED INFORMATION REGARDING COMPLAINT (B)(4). IF THERE IS ANYTHING ELSE NEEDED I WILL BE HAPPY TO GATHER THE INFORMATION. KINDLY ACKNOWLEDGE NO HARM WAS CAUSED AS A RESULT OF THIS COMPLAINT. NO HARM CAME TO THE PATIENT AND HIS MEDICATION CONTINUED TO INFUSE. PLEASE PROVIDE THE LOT NUMBER OF THE EXTERNAL BATTERY. LOT # 15079-111-0001 OR M826150791110001J. HAS THE ISSUE OCCURRED DURING TREATMENT? IF SO, PLEASE PROVIDE A FULL DETAILED DESCRIPTION OF THE TREATMENT SETTINGS: YES, PATIENT WAS RECEIVING HYDROMORPHONE VIA THE SAPPHIRE PUMP. AT APPROXIMATELY 0915, THE PUMP STARTED BEEPING DUE TO LOW BATTERY. THE NURSE WENT IN AND CHANGED THE BATTERIES, BUT COULD NOT TELL IMMEDIATELY IF THE BATTERIES WERE CHARGING THE UNIT SO SHE LEFT AND ADVISED THE FAMILY THAT SHE WOULD RETURN IN 5 MINUTES. ONCE SHE RETURNED, SHE PICKED UP THE PUMP AND NOTICED THAT THE BACK WAS EXTREMELY WARM AND IMMEDIATELY TOOK IT OFF THE UNIT. WHEN SHE OPENED THE UNIT, SHE NOTICED THAT IT HAD AN ORDER AND A WISP OF SMOKE WAS NOTED COME FROM THE OPEN BATTERY PACK. SHE TOOK THE BATTERY PACK OUT OF THE ROOM AND BROUGHT IT TO THE NURSES STATIONS WHERE WE OBSERVED THAT THE SIXTH BATTERY HAD BEEN PLACED INCORRECTLY. ONCE ALL OF THE BATTERIES WERE REMOVED IT WAS NOTICED THAT THE BOTTOM OF THE UNIT HAD BECOME WARPED FROM THE HEAT AND THERE WAS ACID ON THE DOOR OF THE BATTERY PACK. THE SAPPHIRE PUMP WAS NOT DAMAGED. RATE: CONTINUOUS RATE OF 0.5MG/HR WITH A DEMAND DOSE OF 1 MG Q 15. VTBI: 100MLS; TIME: APPROXIMATELY 0900; MODE: PCA + CONTINUOUS; SINGLE AIR VALUE: UNKNOWN; ACCUMULATED AIR VALUE: UNKNOWN; WHICH ADMINISTRATION SET USED WAS (TYPE AND LOT NUMBER): 12003-000-0020. WHAT DRUG WAS BEING ADMINISTERED DURING THE EVENT? HYDROMORPHONE. WHAT WAS THE DRUG CONCENTRATION: 1MG:1ML. WHAT PRIMING METHOD (MANUAL / WITH PUMP) WAS USED? WITH THE PUMP 4. PLEASE PROVIDE A PHOTO DEMONSTRATING THE PROBLEM. ANY OTHER RELEVANT INFORMATION WILL BE APPRECIATED."

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED FROM A CUSTOMER FROM USA: BATTERY PACK OVERHEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94702 SAPPHIRE EXTERNAL BATTERY PACK BATTERY PACK MRZ Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1