BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS - FLOW STOP

    MDR report key: 15076232 · Received July 21, 2022

    Report

    Report Number
    3012307300-2022-13866
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 31, 2023
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586032370
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ALSO SENT REPORT TO FDA IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURING DATE AND D4: DEVICE EXPIRATION DATE COULD NOT BE DETERMINED D4: DEVICE SERIAL NUMBER/LOT NUMBER IS UNKNOWN H6: HEALTH IMPACT AND EVALUATION CODES: UPDATED H10: NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ONE (1) UNIT OF UNKNOW PART NUMBER WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING, IN USED CONDITION, AND NOT DECONTAMINATED INSIDE A BAG. THE COMPLAINANT RETURNED UNIT IS AN RRA ADMINISTRATION SET WHICH DOES NOT CORRESPOND TO THE PART NUMBERS AND DESCRIPTION REPORTED BY THE CUSTOMER. THE UNIT WAS SENT FROM THE DECONTAMINATION CENTER WITH A NOTE INDICATING THAT THE UNIT WAS NOT ABLE TO BE DECONTAMINATED DUE TO BEING OCCLUDED. THE RETURNED PRODUCT CANNOT BE FUNCTIONALLY TESTED AS IT WAS NOT DECONTAMINATED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION RECEIVED ON 16AUGUST2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: EVENT DATE: JUNE 28, 2022; PATIENT DETAILS UPDATED IN COMPLAINT; NO PATIENT HARM WAS REPORTED; THE PATIENT WAS ADMINISTERED A SUPPLEMENTAL DOSE TO MAKE UP FOR MEDICATION LOST DUE TO PUMP MALFUNCTION; THE EVENT WAS RESOLVED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES NOT REQUIRED. H10: DEVICE EVALUATION WAS COMPLETED. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 IF ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED PER CUSTOMER FORM: THAT 5-FU PUMP WAS ORDERED ON (B)(6) 2022, 8640MG (172.8ML), QS?D WITH 77.2ML NS TO A TOTAL VOLUME OF 250ML. PUMP NUMBER (B)(4) WAS SET AT A RATE OF 2.6ML/HOUR FOR 96 HOURS. PATIENT WAS SEEN IN OFFICE ON (B)(6) 2022 FOR PUMP DC. IT WAS NOTED THAT THE PUMP SHOWED THAT 248.2ML WAS GIVEN BUT RESERVOIR BAG STILL LOOKED HALF FULL. THE PUMP AND BAG WERE SENT BACK TO FACILITY TO WITHDRAW THE REMAINDER FROM THE BAG. THERE WAS 141ML LEFT IN THE BAG ((B)(4)), SO ONLY A TOTAL OF 109ML ((B)(4)) WAS ACTUALLY GIVEN. THIS INFORMATION HAS BEEN GIVEN TO THE PROVIDER. PATIENT WAS RECEIVING FLUOROURACIL AND NS. PUMP HAS BEEN SET ASIDE TO RETURN AS DEFECTIVE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263100 CADD CASSETTE RESERVOIRS - FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7308-24 10610586032370

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female