BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MW5077971

    MDR report key: 7624675 · Received June 20, 2018

    Report

    Report Number
    MW5077971
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    April 2, 2018
    Report Date
    April 2, 2018
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S PUMP CADD MS3 SN: (B)(4) WAS ALERTING WITH "KEY STUCK". THE PT CHANGED THE BATTERY AND TRIED TO LOAD THE CARTRIDGE. DURING THE PROCESS THE KEYS WILL NOT ALLOW THE PT TO ADVANCE. SHE SWITCHED TO HER BACKUP PUMP WITHOUT ISSUE. SHE DID NOT HAVE A LAPSE IN THERAPY. THE PT IS BEING SENT A REPLACEMENT PUMP AND SHE WILL SEND BACK THE MALFUNCTIONING PUMP FOR REVIEW ONCE RECEIVED. DOSE OR AMOUNT: 60.20 NG/KIG/MIN, FREQUENCY: CONTINUOUS, ROUTE: SUBCUTANEOUS. DATES OF USE: FROM (B)(6) 2018 TO ONGOING, DIAGNOSIS OR REASON FOR USE: I27.0 PRIMARY PULMONARY HYPERTENSION.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR