BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12" (30 CM) APPX 0.60ML SMALLBORE EXT SET W/ 0.22 MICRON AIR ELIMINATING FILTER,

    MDR report key: 10346111 · Received July 30, 2020

    Report

    Report Number
    9617594-2020-00276
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 8, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: RECEIVED: ONE (1) LIST# Z2600, 12" (30 CM) APPX 0.60ML SMALLBORE EXT SET W/ 0.22 MICRON AIR ELIMINATING FILTER, CLAMP, ROTATING LUER. LOT# UNKNOWN ON AUGUST 28, 2020 FOR EVALUATION. ONE (1) USED LIST# Z2600, 12" (30 CM) APPX 0.60ML SMALLBORE EXT SET W/ 0.22 MICRON AIR ELIMINATING FILTER, CLAMP, ROTATING LUER (LOT# UNKNOWN) WAS RECEIVED AND VISUALLY INSPECTED. AS RECEIVED, THE FILTER WAS FILLED WITH PRIOR INFUSATE. NO FOREIGN MATTER WAS IDENTIFIED. NO DAMAGE OR ANOMALIES WERE FOUND ON THE SET. AN ATTEMPT TO PRIME THE SET WITH WATER AT GRAVITY PRESSURE WAS MADE. THE SET COULD NOT BE PRIMED. THE 0.2 MICRON FILTER WAS CONFIRMED TO BE OCCLUDED. THE PROBABLE CAUSE OF THE OCCLUSION IS THE FILTER BECOMING CLOGGED WITH INFUSATE SOLUTION DURING USE. THE DIRECTIONS FOR USE (DFU) STATES: A FILTER THAT CLOGS DURING INFUSION SHOULD BE REPLACED. A DEVICE HISTORY REVIEW (DHR) LOT REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATING THAT D10W WAS INFUSING. THE OCCLUSION WAS NOTICED WITHIN ONE HOUR OF START OF INFUSION.

    Additional Manufacturer Narrative · 1

    NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. A DEVICE HISTORY REVIEW (DHR) LOT REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 12" (30 CM) APPX 0.60ML SMALLBORE EXT SET W/ 0.22 MICRON AIR ELIMINATING FILTER, CLAMP, ROTATING LUER THAT THE CUSTOMER REPORTED FOREIGN MATTER THAT OCCLUDED THE FILTER CAUSING THE PUMP TO OCCLUDE. THE PRODUCT WAS USED TOGETHER WITH CL CONTINU-FLO SOLN SET, 2 LAV. THE CUSTOMER STATED THERE WAS A WHITE SUBSTANCE JUST BEFORE THE FILTER THAT MAY ACTUALLY BE FILTER PAPER. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF HARM AND NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810007 12" (30 CM) APPX 0.60ML SMALLBORE EXT SET W/ 0.22 MICRON AIR ELIMINATING FILTER, STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 CL CONTINU-FLO SOL SET,2 LAV,BAXTER#2C8219 UNK LOT| D10W| INFUSION PUMP, UNK MFR