BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET WITH FLOW STOP

    MDR report key: 15077828 · Received July 21, 2022

    Report

    Report Number
    3012307300-2022-13908
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    May 5, 2022
    Report Date
    October 12, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586020315
    PMA / PMN Number
    K942046
    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

    CUSTOMER REPORTED TO THE FDA IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: NO SAMPLE WAS RECEIVED FOR EVALUATION. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION RECEIVED ON (B)(6)2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: EVENT DATE: (B)(6) 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., CORRECTED DATA: D4: CORRECTION: DEVICE EXPIRATION DATE: 14-MAR-2027 H4: CORRECTION: DEVICE MANUFACTURING DATE: 09-APR-2022

    Description of Event or Problem · 0

    IT WAS REPORTED PER CUSTOMER FORM: 5-FU PUMP WAS ORDERED ON 6/28/2022, 8640MG (172.8ML), QS?D WITH 77.2ML NS TO A TOTAL VOLUME OF 250ML. PUMP WAS SET AT A RATE OF 2.6ML/HOUR FOR 96 HOURS. PATIENT WAS SEEN AT 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 OFFICE WHERE THE REMAINDER OF THE CONTENTS WERE WITHDRAWN. THERE WAS 141ML LEFT IN THE BAG (4873MG), SO ONLY A TOTAL OF 109ML (3767MG) WAS ACTUALLY GIVEN. THIS INFORMATION HAS BEEN GIVEN TO THE PROVIDER. PATIENT WAS RECEIVING FLUOUROURACIL AND NS. I HAVE SET THE PUMP ASIDE TO BE RETURNED TO FACILITY AS DEFECTIVE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241276 CADD ADMINISTRATION SET WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7047-24 4257062 10610586020315

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female