BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 8001750 · Received October 24, 2018

    Report

    Report Number
    9616066-2018-02001
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    October 1, 2018
    Report Date
    October 1, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403227998
    PMA / PMN Number
    K944320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT THAT FLUID FLOWED FROM THE SECONDARY TO THE PRIMARY WAS CONFIRMED. THE PRIMARY AND SECONDARY SET WERE VISUALLY INSPECTED AND NO ANOMALIES WERE OBSERVED. THE CHECK VALVE WAS INSPECTED UNDER MAGNIFICATION AND FOUND TO BE ASSEMBLED IN THE SET CORRECTLY WITH THE SILICONE MEMBRANE CENTERED. FUNCTIONAL TESTING RESULTED IN BACKFLOW PAST THE CHECK VALVE INDICATING A FAILING CHECK VALVE. DISASSEMBLY OF THE CHECK VALVE RESULTED IN DISCOVERY OF A PARTICLE LOCATED BETWEEN THE HOUSING SEAL AREA AND THE AFFIXED SILICONE DIAPHRAGM DISK. THE PARTICLE WAS IDENTIFIED TO BE CELLULOSE AND BLUE FIBER. THE ROOT CAUSE OF THE BACKFLOW FAILURE IS A PARTICLE FOUND IN THE FLUID PATH THAT PREVENTED THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING SEAL AREA. THE ORIGIN OF THE PARTICLE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE USER PROGRAMMED A SECONDARY INFUSION OF POTASSIUM CHLORIDE 20 MEQ/100ML AT A RATE OF 20ML/HR. WITHIN 10 MINUTES, THE USER NOTED THAT THE SECONDARY BAG WAS COMPLETELY EMPTIED. THE PHYSICIAN WAS NOTIFIED AND A CMPL (COMPREHENSIVE METABOLIC PANEL) WAS ORDERED; RESULTS WERE NORMAL. IT WAS REPORTED THAT THE FIRST POTASSIUM CHLORIDE RIDER HAD INFUSED WITHOUT DIFFICULTY. THERE WAS NO PATIENT HARM REPORTED. THE ENTIRE SET UP WAS TAKEN TO BIOMED FOR FURTHER TESTING. IT WAS REPORTED THAT BOTH THE PCU AND PUMP MODULE PASSED THE CHECK IN PROCEDURE TWICE; THE BEZEL ASSEMBLY WAS INSPECTED WITH NO CRACKS NOTED. THE PRIMARY TUBING WAS NOTED TO HAVE "BUBBLES OR HOLES" ON THE CHECK VALVE AND MORE FLUID VOLUME WAS IN THE PRIMARY BAG OF NORMAL SALINE THAN EXPECTED. IT WAS DETERMINED BY THE CUSTOMER THAT FLUID HAD BACK FLOWED FROM THE SECONDARY INTO THE PRIMARY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MS3500-15. 150ML HOSPIRA BAG, NDC0409-7983-61, LOT91-035-JT, EXP1JULY2020, 0.9% NACL. 100ML BAXTER BAG, NDC0338-0705-48, LOT P380691, EXPJULY19, KCL. THERAPY DATE: (B)(6) 2018. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE USER PROGRAMMED A SECONDARY INFUSION OF POTASSIUM CHLORIDE 20 MEQ/100ML AT A RATE OF 20ML/HR. WITHIN 10 MINUTES, THE USER NOTED THAT THE SECONDARY BAG WAS COMPLETELY EMPTIED. THE PHYSICIAN WAS NOTIFIED AND A CMPL (COMPREHENSIVE METABOLIC PANEL) WAS ORDERED; RESULTS WERE NORMAL. IT WAS REPORTED THAT THE FIRST POTASSIUM CHLORIDE RIDER HAD INFUSED WITHOUT DIFFICULTY. THERE WAS NO PATIENT HARM REPORTED. THE ENTIRE SET UP WAS TAKEN TO BIOMED FOR FURTHER TESTING. IT WAS REPORTED THAT BOTH THE PCU AND PUMP MODULE PASSED THE CHECK IN PROCEDURE TWICE; THE BEZEL ASSEMBLY WAS INSPECTED WITH NO CRACKS NOTED. THE PRIMARY TUBING WAS NOTED TO HAVE "BUBBLES OR HOLES" ON THE CHECK VALVE AND MORE FLUID VOLUME WAS IN THE PRIMARY BAG OF NORMAL SALINE THAN EXPECTED. IT WAS DETERMINED BY THE CUSTOMER THAT FLUID HAD BACK FLOWED FROM THE SECONDARY INTO THE PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840235 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0007 18055027 10885403227998

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PRI TUBING, SEC TUBING, 8015, (2) 8100, TD (B)(6) 2018| PRI TUBING, SEC TUBING, 8015, (2) 8100, TD (B)(6) 2018