BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 9865918 · Received March 23, 2020

    Report

    Report Number
    9616066-2020-01019
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    August 4, 2019
    Report Date
    February 24, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403232343
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT THAT THE SET WAS LEAKING AT THE MICRON FILTER WAS CONFIRMED. THE SET WAS VISUALLY INSPECTED FOR OBVIOUS DAMAGE SUCH AS CRACKS, KINKS, HOLES, AND TEARS IN THE TUBING AND ITS COMPONENTS. LIGHT YELLOW LIQUID WAS OBSERVED WITHIN THE MICRON ADULT FILTER AND THROUGHOUT THE SET. STICKY RESIDUE WAS NOTED ON THE SURFACE OF THE SET¿S FILTER. NO ANOMALIES OR EVIDENCE OF DAMAGE WERE OBSERVED ON THE FILTERS OR THE SET UPON INITIAL VISUAL INSPECTION. THE SET OBSERVED SMALL DROPLETS OF FLUID LEAKING FROM THE MICRON FILTER¿S TOP AND BOTTOM AIR VENT (TERMED ¿WEEPING OUT¿). THE SET WAS PRESSURE TESTED AND SMALL DROPLETS OF FLUID LEAKING FROM THE MICRON FILTER¿S TOP AND BOTTOM AIR VENT. THE ROOT CAUSE OF THE LEAK WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NURSE NOTICED YELLOW FLUID ON THE BED. UPON CHECKING THE TUBING, A SMALL LEAK WAS NOTED AT THE FILTER. TOTAL PARENTERAL NUTRITION (TPN) 3.8ML/HR OVER 24 HOURS WAS INFUSING AT THE TIME OF THE EVENT. THE CENTRAL LINE NURSE AND NEONATAL NURSE PRACTITIONER (NNP) WERE NOTIFIED, BOTH CAME TO BEDSIDE AND ASSESSED THE TUBING. STARTER TPN AND GLUCOSE CHECK WERE ORDERED BY NNP, THE BLOOD GLUCOSE READING WAS 97MG/DL, AND THE TPN WAS HUNG BY THE CENTRAL LINE NURSE AT 1015. THE EVENT OCCURRED AT NEONATAL INTENSIVE CARE UNIT (NICU). THERE WAS NO PATIENT INJURY. THE CUSTOMER PROVIDED A PHOTO OF THE INVOLVED PRODUCT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION. PER CUSTOMER, THE REQUESTED PATIENT DEMOGRAPHICS IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE NOTICED YELLOW FLUID ON THE BED. UPON CHECKING THE TUBING, A SMALL LEAK WAS NOTED AT THE FILTER. TOTAL PARENTERAL NUTRITION (TPN) WAS INFUSING AT THE TIME OF THE EVENT. THE CENTRAL LINE NURSE AND NEONATAL NURSE PRACTITIONER (NNP) WERE NOTIFIED, BOTH CAME TO BEDSIDE AND ASSESSED THE TUBING. STARTER TPN AND GLUCOSE CHECK WERE ORDERED BY NNP, THE BLOOD GLUCOSE READING WAS 97MG/DL, AND THE TPN WAS HUNG BY THE CENTRAL LINE NURSE AT 1015. THE EVENT OCCURRED AT NEONATAL INTENSIVE CARE UNIT (NICU). THERE WAS NO PATIENT INJURY. THE CUSTOMER PROVIDED A PHOTO OF THE INVOLVED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333557 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 11532269 10885403232343

    Patients

    Seq Age Sex Outcome Treatment
    1 8100,8015, THERAPY DATE: (B)(6) 2019.| 8100,8015, THERAPY DATE: (B)(6) 2019.