BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® SYRINGE MODULE

    MDR report key: 5907052 · Received August 26, 2016

    Report

    Report Number
    2016493-2016-00619
    Event Type
    Malfunction
    Date Received
    August 26, 2016
    Date of Event
    July 28, 2016
    Report Date
    August 1, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: (2) 30883; MONOJECT 60ML SYRINGE; THERAPY DATE (B)(6) 2016. THE CUSTOMER¿S REPORT OF LESS FLUID IN THE BAG THAN EXPECTED COULD NOT BE CONFIRMED. A CAREFUSION/BD EXTENSION SET WAS RECEIVED ATTACHED VIA A NON-CFN/BD T-TYPE EXTENSION SET TO A NON CFN/BD PRIMARY SET WHICH WAS ATTACHED TO A 250 ML FLUID BAG. THE LOG ANALYSIS COULD NOT ASCERTAIN THE ACTUAL BAG VOLUME AT THE START OR END OF THE INFUSION. INSPECTION OF THE SYRINGE MODULE AND RETURNED DISPOSABLE SET-UP SHOWED NO MALFUNCTIONS. A TEST INFUSION WITH THE CLAMP CLOSED ON THE NON-CFN/BD PRIMARY SET RESULTED IN NORMAL INFUSION VIA THE SYRINGE MODULE AND NO CHANGE IN THE VOLUME OF THE BAG CONNECTED TO THE PRIMARY SET. A TEST INFUSION WITH THE CLAMP OPEN ON THE PRIMARY SET REPLICATED A CHANGE IN BAG VOLUME DURING THE INFUSION. WITH THE CLAMP ON THE PRIMARY SET LEFT OPEN DURING THE INFUSION, CONCURRENT FLOW WOULD OCCUR DECREASING THE VOLUME IN THE BAG. THE ROOT CAUSE OF LESS FLUID IN THE BAG THAN EXPECTED COULD NOT BE DEFINITIVELY DETERMINED, HOWEVER CONCURRENT FLOW FROM THE IV BAG OCCURRED IF THE CLAMP ON THE PRIMARY TUBING WAS NOT CLOSED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: IN LINE SET WITH CHECK VALVE AND L5102-5% DEXTROSE BAG." MODEL NUMBER NOT KNOWN; SYRINGES; 250ML B.BRAUN NDC 0264-7510-20, LOT J5K295, EXP 08/17, 5% DEXTROSE INJECTION); YELLOW SPIKE TUBING (UNKNOWN MANUFACTURER); EXTENSION TUBING WITH CLAVE CONNECTOR (UNKNOWN MANUFACTURER); MICROBORE EXTENSION PIECE (CFN/BD) 30883; THERAPY DATE (B)(6) 2016. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN INFUSION IN THE PROCEDURE ROOM, LESS FLUID THAN EXPECTED WAS OBSERVED IN THE IV BAG. NO FLUID OBSERVED ON THE FLOOR OR IN THE PATIENTBED. IV WAS PATENT AND INFUSING WELL. SET AND DEVICES WERE SAVED FOR INVESTIGATION. NO PATIENT HARM WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560415 ALARIS® SYRINGE MODULE PUMP, INFUSION FRN CAREFUSION 8110

    Patients

    Seq Age Sex Outcome Treatment
    1