BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MS3 INFUSION CARTRIDGE

    MDR report key: 13283123 · Received January 18, 2022

    Report

    Report Number
    3012307300-2022-01005
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Report Date
    January 18, 2022
    Manufacturer
    NULL
    Product Code
    FRN
    PMA / PMN Number
    K051568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL CONTACT INFORMATION: PHARMACY INFORMATION: (B)(6).PRESCRIBER INFORMATION: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL CONTACT INFORMATION: PHARMACY INFORMATION: (B)(6). PRESCRIBER INFORMATION: (B)(6).

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A CADD MS3 PUMP USING A CADD MS3 CARTRIDGE HAD SOMETHING STUCK IN THE PUSH ROD CHAMBER OF THE CARTRIDGE. IT WAS REPORTED THE END USER WAS HAVING A SEVERE SKIN REACTION TO THE PLO GEL FORMULA D, THE AREA WHERE THE PLO GEL WAS PLACED REPORTEDLY BLISTERED AND THE END USER BROKE OUT. PER REPORTER THE SKIN IRRITATION SEEMS TO BE HEALING AND THE PUMP WAS REPLACED. REMODULIN 10MG/ML; ORENITRAM 5MG, ORENITRAM 1.0MG. DOSE;12 NG/KG/MIN SUBCUTANEOUS ORENITRAM DOSE 11 MG THREE TIME DAILY: ORAL. CONTINUOUS (B)(6) 2021 TO CURRENT. LOT 2101926; 2101844, EXPIRATION DATE (B)(6) 2022; (B)(6) 2023. LOT 2102020, EXPIRATION DATE (B)(6) 2022. PULMONARY ARTERIAL HYPERTENSION (PAH).

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A CADD MS3 PUMP USING A CADD MS3 CARTRIDGE HAD SOMETHING STUCK IN THE PUSH ROD CHAMBER OF THE CARTRIDGE. IT WAS REPORTED THE END USER WAS HAVING A SEVERE SKIN REACTION TO THE PLO GEL FORMULA D, THE AREA WHERE THE PLO GEL WAS PLACED REPORTEDLY BLISTERED AND THE END USER BROKE OUT. PER REPORTER THE SKIN IRRITATION SEEMS TO BE HEALING AND THE PUMP WAS REPLACED. REMODULIN 10MG/ML; ORENITRAM 5MG, ORENITRAM 1.0MG. DOSE;12 NG/KG/MIN SUBCUTANEOUS ORENITRAM DOSE 11 MG THREE TIME DAILY: ORAL. CONTINUOUS (B)(6) 2021 TO CURRENT. LOT 2101926; 2101844, EXPIRATION DATE 11/30/2022; 04/30/2023. LOT 2102020, EXPIRATION DATE 11/20/2022. PULMONARY ARTERIAL HYPERTENSION (PAH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948080 CADD MS3 INFUSION CARTRIDGE PUMP, INFUSION FRN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown