BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360 DRIVER NEW

    MDR report key: 8732841 · Received June 25, 2019

    Report

    Report Number
    9615050-2019-00204
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 5, 2019
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF "THERE MAY HAVE BEEN AN OVER INFUSION ON THE PUMP" WAS NOT CONFIRMED. LCD DISPLAY BROKEN DUE TO PHYSICAL DAMAGE (MISSED HANDLING AT THE REPAIR HUB) AND REPLACED. DEVICE LOG WAS SENT TO ENGINEER FOR ANALYSIS AND FOUND: "EXAMINATION OF THE CLINICAL LOGS VERIFY THAT THERE WAS A THERAPY PROGRAMMED AT (B)(6) 2019 20:23:42.024 CDT AND STARTED AT (B)(6) 2019 20:23:45.100 CDT. THE PROGRAMMED RATE WAS 390.0 ML/HR. THE PROGRAMMED VTBI WAS 780 ML. THE ENTERED DILUENT VOLUME WAS 750 ML. THIS THERAPY RAN UNTIL IT WAS STOPPED BY A PROXIMAL AIR IN LINE ALARM AT (B)(6) 2019 21:13:48.719 CDT. THIS ALARM COULD BE AN INDICATION OF AN EMPTY DRUG CONTAINER. THE DEVICE RECORDED A TOTAL DELIVERY VOLUME OF 326.2 ML. THIS IS CONSISTENT WITH THE THERAPY DURATION AND PROGRAMMED RATE WITHIN THE PUMPS STATED ACCURACY OF +/- 5%: 50 MINUTES X (1 HR/60 MIN) * 390.0 ML/HR = 325 ML." DEVICE PASSED SELF-TEST. DEVICE WAS PROGRAMMED TO INFUSED: PEDI ONCOLOGY, LINE A, ETOPOSIDE, WEIGHT 66.7KG, RATE 390 ML/HR, VTBI 780 ML. DEVICE COMPLETED THE INFUSION WITHOUT ERROR AND DISPLAYED VOL INF 780 ML. THE ACTUAL FLUID COLLECTED WAS 779.2G=779.2 ML. (-0.1% ACCURACY). NO PROBABLE CAUSE FOR "THERE MAY HAVE BEEN AN OVER INFUSION ON THE PUMP" AND "PROXIMAL AIR IN LINE ALARM" AS DEVICE PASSED TESTING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED JULY 9, 2019 STATING ON (B)(6) 2019 21:13:48 LINE: A, DELIVERY STOPPED: VTBI (VOLUME TO BE INFUSED): 453, PATIENT WEIGHT: 113.0 KG, TOTAL VOLUME INFUSED: 326.2, MODE: CONTINUOUS. IT WAS ALSO REPORTED THE DEVICE SAID 453 VTBI SHOULD BE LEFT, BUT THERE WAS NOTHING IN THE BAG.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION. IT IS NOT RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVES A PLUM 360 DEVICE THAT THERE MAY HAVE BEEN AN OVER INFUSION ON THE PUMP WHEN THE PUMP DELIVERED ETOPOSIDE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526011 PLUM 360 DRIVER NEW PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 ETOPOSIDE.