BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED CADD MEDICATION CASSETTE

    MDR report key: 21118830 · Received January 9, 2025

    Report

    Report Number
    3012307300-2025-00541
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 1, 2024
    Report Date
    January 9, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6). H3, H6: NO PRODUCT WAS RETURNED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT CONDUCTED AS THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CASSETTE FROM THE PATIENT¿S LAST ORDER LEAKED MEDICATION. THE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 10.0 MG/ML) DELIVERED VIA A SELF-FILLED PUMP. THE CURRENT DOSE WAS REPORTED AS 0.082 G/KG, SELF-FILLED WITH 3 ML PER CASSETTE AT A PUMP RATE OF 38 MCL/HOUR, CONTINUOUS VIA SUBCUTANEOUS (SQ) ROUTE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169736 UNSPECIFIED CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female ALBUTEROL SULFATE HFA| ALLOPURINOL| AMITRIPTYLINE| ATORVASTATIN CALCIUM| BUMETANIDE| CINACALCET| CLEO INFUSION SET| CLONIDINE| FISH OIL| GABAPENTIN| GLIPIZIDE| KETAMINE| KETOPROFEN| LECITHIN| LIDOCAINE| LOPERAMIDE| METOPROLOL SUCCINATE| MULTIVITAMIN| OXYGEN| POLOXAMER| POTASSIUM CHLORIDE| REMODULIN (TREPROSTINIL SODIUM) SQ ROUTE10.0 MG/ML| REMUNITY PUMP| SILDENAFIL CITRATE| TYLENOL (PARACETAMOL)| WARFARIN SODIUM| ZYRTEC (CETIRIZINE HYDROCHLORIDE)