BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION

    MDR report key: 16292106 · Received February 3, 2023

    Report

    Report Number
    3012307300-2023-00838
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 5, 2023
    Report Date
    October 4, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO PRODUCT RETURNED TO VERIFY OR REPLICATE THE COMPLAINT. NO PHOTOGRAPHIC/ DIAGNOSTIC EVIDENCE OF COMPLAINT PROVIDED BY THE CUSTOMER. THEREFORE, THE CUSTOMER COMPLAINT WAS NOT DUPLICATED. THE MOST PROBABLE CAUSE IS AN INOPERABLE "DSO" SENSOR. NO SERIAL NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD (DHR) REVIEW AND SERVICE HISTORY COULD NOT BE PERFORMED. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA EMAIL. THE REPORTED SERIAL NUMBER OF THE PUMP: 4163656 IS NOT A VALID NUMBER. TOTAL PARENTERAL NUTRITION IS THE ONLY FORM OF NUTRITION THE CHILD HAS BECAUSE OF SHORT BOWEL DISEASE. THEY USED ANOTHER PUMP FOR TOTAL PARENTERAL NUTRITION. THE OUTCOME OF THE EVENT WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CHILD HAVE NOT HAD ANY TOTAL PARENTERAL NUTRITION LAST INFUSION. INFUSION LOG SHOW THAT PUMP HAS STARTED AND THE INFUSION HAVE BEEN ON CONTINUOUS INFUSION. WHEN PUMP ALARMED RESERVOIR VOLUME LOW, WEIGHT CONTROL OF INFUSION BAG SHOW THAT NO TPN HAVE INFUSED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955657 PUMP, INFUSION FRN ST PAUL

    Patients

    Seq Age Sex Outcome Treatment
    1 Male