BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 8380646 · Received February 28, 2019

    Report

    Report Number
    9616066-2019-00516
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    January 18, 2019
    Report Date
    February 6, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A BULGE IN THE SILICONE SEGMENT WAS CONFIRMED. VISUAL INSPECTION OBSERVED THAT AT THE TOP OF THE SILICONE PUMP SEGMENT NEAR THE UPPER FITMENT, THE TUBING LOOKED DEFORMED AND WEAKENED AS IF IT HAD PREVIOUSLY BEEN BALLOONED. FUNCTIONAL TESTING SHOWED NO ANOMALIES. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT COULD NOT BE DETERMINED AS NO BALLOONING WAS REPLICATED DURING INTERNAL LAB TESTING. THE CUSTOMER¿S REPORT OF A DISCONNECTION AND LEAK WAS NOT CONFIRMED. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF A DISCONNECTION AND LEAK COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A PPN (2000 ML AMINO ACID 2.75% WITH DEXTROSE AND ELECTROLYTES) INFUSION PROGRAMMED AT A RATE OF 80ML/HR , THE RN FOUND PPN LINE DISCONNECTED FROM THE FILTER EXTENSION AND NOTICED THE PPN LINE WAS ON THE FLOOR AND THE IV CLOTTED OFF. THERE WERE NO AUDIBLE DEVICE ALARMS NOTED. IT WAS LATER OBSERVED BY THE RN THAT THE PPN TUBING HAD A BULGE IN THE SILICONE SEGMENT. THE PATIENT PPN INFUSION WAS STOPPED (DUE TO BE DISCONTINUED THAT DAY) AND THE IV LINE REMOVED, BOTH DEVICES AND SETS WERE TAKEN TO BIOMED. THE FACILITY REPORTED THAT TUBING IS CHANGED EVERY 24 HRS. THERE WAS NO PATIENT HARM INDICATED BY THE CUSTOMER. IT WAS LATER REPORTED BY THE BIOMED DEPARTMENT THAT THE "DEVICE HAD PROBABLE PRESSURE SENSOR FAILURE. HE STATED :DURING OUR INVESTIGATION, WE RAN THROUGH THE CALIBRATION PROCESS FOR THE 8100. IT WAS OUT OF SPECIFICATION. WE COULD NOT CALIBRATE IT TO WITHIN SPECIFICATIONS. THE PRESSURE SENSORS HAVE NOT BEEN REPLACED".

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION. BOWEL OBSTRUCTION,WT. 65.10 KG.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PPN (2000 ML AMINO ACID 2.75% WITH DEXTROSE AND ELECTROLYTES) INFUSION PROGRAMMED AT A RATE OF 80ML/HR , THE RN FOUND PPN LINE DISCONNECTED FROM THE FILTER EXTENSION AND NOTICED THE PPN LINE WAS ON THE FLOOR AND THE IV CLOTTED OFF. THERE WERE NO AUDIBLE DEVICE ALARMS NOTED. IT WAS LATER OBSERVED BY THE RN THAT THE PPN TUBING HAD A BULGE IN THE SILICONE SEGMENT. THE PATIENT PPN INFUSION WAS STOPPED (DUE TO BE DISCONTINUED THAT DAY) AND THE IV LINE REMOVED, BOTH DEVICES AND SETS WERE TAKEN TO BIOMED. THE FACILITY REPORTED THAT TUBING IS CHANGED EVERY 24 HRS. THERE WAS NO PATIENT HARM INDICATED BY THE CUSTOMER. IT WAS LATER REPORTED BY THE BIOMED DEPARTMENT THAT THE "DEVICE HAD PROBABLE PRESSURE SENSOR FAILURE. HE STATED :DURING OUR INVESTIGATION, WE RAN THROUGH THE CALIBRATION PROCESS FOR THE 8100. IT WAS OUT OF SPECIFICATION. WE COULD NOT CALIBRATE IT TO WITHIN SPECIFICATIONS. THE PRESSURE SENSORS HAVE NOT BEEN REPLACED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173238 ALARIS® PUMP MODULE ADMINISTRATION SET SET,ADMINISTRATION.INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 8100,8015,EXT TUBING, TD (B)(6) 2019| NON-BD FILTER EXTENSION SET , TD (B)(6) 2019