BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY CASSETTE

    MDR report key: 17309327 · Received July 11, 2023

    Report

    Report Number
    MW5119301
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Report Date
    July 6, 2023
    Manufacturer
    UNITED THERAPEUTICS/DEKA RESEARCH & DEVELOPMENT CORP.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS REPORT FROM PATIENT'S MOTHER WHO REPORTED THAT THE PATIENT IS OUT OF REMODULIN BECAUSE YESTERDAY SHE HAD ISSUES WHEN MAKING THE NEW CASSETTE AND SHE ENDED UP WASTING MEDICATION FOR 2 CASSETTES. SHE REPORTED THAT WHEN SHE MADE THE FIRST CASSETTE, THE TIP OF THE NEEDLE BROKE INSIDE AND THE SECOND CASSETTE WAS LEAKING. BOTH CASSETTES WERE DISCARDED. SHE DID NOT PROVIDE ANY LOT NUMBERS FOR THE AFFECTED CASSETTES. THE THIRD CASSETTE CREATED YESTERDAY WAS FINE AND THAT IS WHAT THE PATIENT IS CURRENTLY USING. PATIENT IS ON SUBCUTANEOUS REMODULIN THERAPY USING REMUNITY PUMPS. PATIENT'S MOTHER DID NOT REPORT THAT PATIENT EXPERIENCED ANY CHANGES IN BREATHING OR SIDE EFFECTS. NO OTHER INFORMATION PROVIDED. SUBCUTANEOUS SELF-FILL REMUNITY PT. PT ACTIVELY ON UPTRAVI AND TADALAFIL. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? PLEASE EXPLAIN. N/A. IS THE CASSETTE AVAILABLE TO BE RETURNED FOR INVESTIGATION? NO. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. DESCRIBE IN DETAIL ANY, AND ALL DAMAGE TO THE CASSETTE. HAS THIS INCIDENT HAPPENED WITHIN THE PAST 6 MONTHS? (OFFER NURSING EVALUATION). REPORTED TO CVS/CAREMARK BY: PATIENT/CAREGIVER. REFERENCE REPORTS: MW5119299, MW5119300.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704868 REMUNITY CASSETTE SET, I.V. FLUID TRANSFER LHI UNITED THERAPEUTICS/DEKA RESEARCH & DEVELOPMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male REMODULIN.| REMUNITY PUMP.| TADALAFIL.| UPTRAVI.