BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MW5081068

    MDR report key: 8042121 · Received November 5, 2018

    Report

    Report Number
    MW5081068
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 19, 2018
    Report Date
    October 31, 2018
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT CONNECTED TO CURLIN 6000 AMBULATORY HOME INFUSION PUMP AT OTHER HOSP (FMLH) AT 1205 (B)(6) 2018 FOR 2.75 MG TRABECTED IN 500 ML 0.9% NACL (TOTAL BAG VOLUME = 605 ML) WITH PLANS TO DISCONNECT AT SJH KCC ON (B)(6) 2018 AT 1200. PER INFUSION RN NOTES FROM (B)(6), "PT ROOMED AT 1305. PT ARRIVED SLIGHTLY LATER FOR APPT. PT STATED THAT SHE HAD TO CALL THE PUMP HELP LINE 3 TIMES BECAUSE THE ALARM WENT OFF. FIRST CALL TO THEM WAS AT 2000 ON (B)(6) 2018 AND THE ASSISTANT MANAGED TO GET THE PUMP SORTED. THEN AGAIN AT 1230PM, THE PT CALLED WITH BUBBLES IN THE LINE AND THE ASSISTANT HELPED THE PT GET THE PUMP GOING AGAIN. PT STATED THAT SHE WAS TOLD TO OPEN THE PUMP AND MASSAGE THE LINE." THE PUMP ALARM WENT OFF TODAY AT 1200 NOON WITH THE MESSAGE "UPPER OCCLUSION". PT CALLED AGAIN AND THE ASSISTANT TOLD HER TO TURN THE PUMP OFF. PT TURNED THE PUMP OFF. CHECKED THE PUMP AT 1306 AND A MESSAGE OF "UPPER OCCLUSION" WAS FLASHING, BAG TOTALLY EMPTY, BUT THE PUMP STATED THERE WAS STILL 22ML NEEDING TO BE INFUSED. THE INFUSED AMOUNT WAS 583ML AND BUBBLES IN THE LINE. PUMP WAS FLAGGED FOR EVALUATION, AND RETURNED TO ORIGINATING HOSPITAL. (B)(6).

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other