BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 5068478 · Received September 10, 2015

    Report

    Report Number
    9616066-2015-01100
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 13, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF UNREGULATED FLUID FLOW WAS CONFIRMED. VISUAL INSPECTION OF THE PUMP MODULE'S DEVICE LATCH SHOWED A DIFFERENT EJECTOR PIN MARKING LOCATION, INDICATING A 3RD PARTY PART. THE CUSTOMER¿S RETURNED SEAR WAS ALSO INSPECTED; THE SEAR WAS FROM A DIFFERENT MOLD BASED ON GATE LOCATION AND EJECTOR PIN SIZES, INDICATING THAT THIS WAS ALSO A 3RD PARTY PART. FUNCTIONAL TESTING WAS PERFORMED. TESTING INDICATED THAT THE SAFETY CLAMP ACTIVATION DID NOT OCCUR WHEN USING THE CUSTOMER¿S PUMP MODULE WITH A NEW DISPOSABLE SET. THE CUSTOMER¿S USED IV SET WAS RECEIVED, HOWEVER NO TESTING WAS DEEMED NECESSARY BECAUSE THE CAUSE OF THE EVENT WAS DETERMINED TO BE RELATED TO THE PUMP MECHANISM THAT FAILED TO ACTIVATE THE SAFETY CLAMP. THE PROXIMATE CAUSE OF THE REPORTED FREE-FLOW WHEN THE DOOR OPENED WAS THE USE OF A 3RD PARTY DOOR LATCH AND SEAR ASSEMBLY.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICES HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SAFETY CLAMP ON A NITROGLYCERINE (NTG) DRIP DID NOT CLOSE WHEN THE CHANNEL DOOR WAS OPENED. THE NTG WAS STILL CONNECTED TO THE PATIENT AND WAS NOTED TO BE "FREE DRIPPING". THIS RESULTED IN A SIGNIFICANT DROP IN THE PATIENT'S BLOOD PRESSURE WHICH REQUIRED (UNSPECIFIED) PRESSOR SUPPORT. A SECOND DISPOSABLE SET WAS SUBSEQUENTLY USED IN THE SAME CHANNEL FOR A PRECEDEX INFUSION; WHEN THE DOOR WAS OPENED TO TAKE THE CHANNEL OUT OF SERVICE FOR BIOMED TO CHECK THE CLINICIAN NOTED IMMEDIATELY THAT THE SAFETY CLAMP DID NOT ENGAGE ON THAT TUBING SET EITHER. THERE WAS NO IMPACT WHEN THE ISSUE HAPPENED WITH THE PRECEDEX DRIP BECAUSE THE CLINICIAN WAS OBSERVING VERY CLOSELY AT THAT TIME WHEN HE OPENED THE DOOR AND REMOVED THE SET. THERE WAS NO LASTING EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598853 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention