BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18" (46 CM) APPX 2.5 ML, EXT SET W/PRE-PIERCED PORT, EASYDROP FLOW CONTROLLER, R

    MDR report key: 15995216 · Received December 16, 2022

    Report

    Report Number
    9617594-2022-00325
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    November 21, 2022
    Report Date
    December 12, 2022
    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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN D4, H4 AND H10 PERTAINING TO POSSIBLE LOT NUMBERS THAT THE CUSTOMER PROVIDED SINCE THE MOST RECENT EMDR SUBMISSION FOR THIS PARTICULAR COMPLAINT. D4 AND H4 - THE SPECIFIC LOT NUMBER OF THE DEVICE THAT WAS ACTUALLY IN USE DURING THE COMPLAINT IS UNKNOWN. THE CUSTOMER IDENTIFIED TWO POSSIBLE LOT NUMBERS: 4943546 (EXPIRY DATE 08/01/2025, MFR DATE 07/01/2020) AND 6038168 (EXPIRY DATE 06/01/2027, MFR DATE 06/01/2022). H10: THE DEVICE HISTORY RECORDS (DHRS) FOR THE POSSIBLE LOT NUMBERS 4943546 AND 6038168 WERE REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SAMPLE WAS RECEIVED FROM THE CUSTOMER AND A COMPLAINT INVESTIGATION WAS PERFORMED: 1 NEW LIST #117420460, 18" (46 CM) APPX 2.5 ML, EXT SET W/PRE-PIERCED PORT, EASYDROP FLOW CONTROLLER, ROTATING LUER; LOT #4943546. THERE WERE NO VISUAL ANOMALIES OBSERVED ON THE RETURNED NEW FLOW CONTROLLER SET. THE NEW FLOW CONTROLLER SET WAS CONNECTED TO A 2 LITER FLEXIBLE BAG OF STERILE WATER AND THE CONTROLLER WAS SET TO 250ML PER HOUR. THE FLUID THROUGH THE FLOW CONTROLLER WAS COLLECTED INTO A GRADUATED CYLINDER IN ORDER TO MEASURE VOLUME OF FLOW THROUGH THE ASSEMBLY. THE MEASURED VOLUME WAS 205ML PER HOUR. THE FLOW CONTROLLER WAS THEN SET TO "OPEN" AND AGAIN THE FLUID VOLUME WAS COLLECTED INTO A GRADUATED CYLINDER. THE FLOW OF A WIDE OPEN CONTROLLER WAS 3,000ML PER HOUR. THE FLOW TESTING INDICATED THAT THE DEVICE DID NOT EXCEED THE SET VOLUME ON THE DIAL. THE COMPLAINT ISSUE OF 'DELIVERING MORE THAN INTENDED' WAS UNABLE TO BE REPLICATED OR CONFIRMED WITH THE NEW FLOW CONTROLLER SET PROVIDED.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AT A VETERINARY CLINIC AND INVOLVED A 18" (46 CM) APPX 2.5 ML, EXT SET W/PRE-PIERCED PORT, EASYDROP FLOW CONTROLLER, ROTATING LUER. THE CUSTOMER THAT THE DEVICE DELIVERED MORE LACTATED RINGERS THAN INTENDED TO THE PATIENT. THERE WAS NO HARM REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 28DEC2023 INDICATING THAT THE SET-UP WAS AS FOLLOWS: A LITER BAG OF FLUIDS, A PRIMARY LINE, A FLOW CONTROLLER EXTENSION SET CONNECTED TO A T-PORT IV CATHETER IN PATIENT. THE FLUID EXPECTED TO BE LEFT WAS ABOUT 700MLS WHEN THE ISSUE WAS NOTED; HOWEVER, THERE WAS NO FLUID LEFT IN THE BAG. IT WAS REPORTED THAT THERE WAS NO PUMP USED AS DEVICE BEING USED WERE SUPPOSED TO BE CONTROLLING FLOW. IT WAS FURTHER STATED THAT THERE WAS NO HARM NOTED ON THE PATIENT AND THAT THE PATIENT WAS MONITORED THE DAY FOLLOWING USE OF THE DEVICE. THERE WAS NO DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484386 18" (46 CM) APPX 2.5 ML, EXT SET W/PRE-PIERCED PORT, EASYDROP FLOW CONTROLLER, R STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LACTATED RINGERS, MFR UNK| LITER BAG OF UNSPECIFIED FLUIDS, MFR UNK| UNSPECIFIED PRIMARY INFUSION LINE, MFR UNK| UNSPECIFIED T-PORT IV CATHETER, MFR UNK