BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMUNITY PUMP

    MDR report key: 17584122 · Received August 18, 2023

    Report

    Report Number
    MW5144759
    Event Type
    Injury
    Date Received
    August 18, 2023
    Report Date
    August 15, 2023
    Manufacturer
    DEKA RESEARCH & DEVELOPMENT CORP.
    Product Code
    QJY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SQ REMUNITY SELF-FILL PT. PER CNSS (B)(6), PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL EARLIER TONIGHT (UNKNOWN REASON, DATES, OR LENGTH OF STAY) AND RETURNED HOME, AND BEGAN HAVING ISSUES WITH HER REMUNITY PUMP. THE PUMP AND REMOTE WOULD NO LONGER PAIR, AND WHEN THE CASSETTE WAS REMOVED FROM THE PUMP IN TROUBLESHOOTING IT BEGAN TO LEAK. HAD PT MAKE A NEW CASSETTE AND USE HER BACKUP PUMP AND ENCOUNTERED THE SAME ISSUES, SO SHE INSTRUCTED PATIENT TO RETURN TO THE HOSPITAL. PER (B)(6), PRIOR TO DISCHARGE SHE HAD OBSERVED THE PATIENT MAKING HER CASSETTE "PERFECTLY" AND STAYED WITH HER FOR OVER AN HOUR AFTER HER REMUNITY INFUSION BEGAN AND IT HAD NO ISSUES DURING THAT TIME. PT ALSO HAD AN ACCIDENTAL REMOVAL OF SUBCUTANEOUS SITE (LEFT UPPER ABDOMEN) - RED, EDEMATOUS, AND PAINFUL. 8/10 PAIN. NO OTHER INFORMATION PROVIDED. PATIENT STARTED USING REMUNITY DEVICE (B)(6) 2023. SN FOR PUMPS- (B)(6) , (B)(6) . PT ACTIVELY ON OPSUMIT AND TADALAFIL. REPORTED TO CVS/CAREMARK BY: HEALTH PROFESSIONAL. REFERENCE REPORT: MW5144760.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405720 REMUNITY PUMP INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY DEKA RESEARCH & DEVELOPMENT CORP. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization OPSUMIT.| TADALAFIL.