BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 16038855 · Received December 22, 2022

    Report

    Report Number
    2243072-2022-02216
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    November 23, 2022
    Report Date
    June 16, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403233645
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET LINE WAS CONTINUALLY ALARMING OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INITIAL INFUSION SET-UP, THE LINE WAS CONTINUALLY ALARMING FOR OCCLUSION. UPON INVESTIGATION, DISCOVERED THAT THE 1.2 -MICRON FILTER ATTACHED TO THE LINE WOULD NOT FLUSH. D1: MEDICAL DEVICE BRAND NAME: BD ALARIS¿ EXTENSION SET. D2: MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D4: UDI#: (B)(4). D4: CATALOG#: 10011865. G2: MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G5: PMA / 510(K)#: K790108.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 10-JAN-2023. H6: INVESTIGATION SUMMARY ONE SAMPLE (MODEL #10011865) WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED BY CUSTOMER THAT THE LINE WAS CONTINUALLY ALARMING FOR OCCLUSION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS ATTEMPTED TO BE FLUSHED WITH WATER USING A BD 10ML SYRINGE. WATER WAS ABLE TO FORCED THROUGH THE SET, BUT WAS MET WITH SOME RESISTANCE. THE RETURNED SET WAS CONNECTED TO A BD PRIMARY SET THAT WAS PRIMED WITH SALINE. AN INFUSION RUN WAS STARTED AT 125 ML / HR, HOWEVER THE PUMP IMMEDIATELY RANG "OCCLUDED - PATIENT SIDE". WHEN THE RETURN SET WAS REMOVED, THE INFUSION WAS COMPLETED WITHOUT ISSUE. THE RETURNED SET WAS EXAMINED UNDER MAGNIFICATION, HOWEVER, NO EXCESS SOLVENT WAS OBSERVED AT THAT TIME. A QUALITY NOTIFICATION WAS SENT TO THE SUPPLIER OF THE FILTER, AND THE SAMPLE WAS SENT FOR FURTHER INVESTIGATION. THE SUPPLIER WAS ABLE TO CONFIRM AN OCCLUSION, BUT FOUND NO FAULT WITH THE FILTER. THE SAMPLE WAS FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THE MANUFACTURER WAS ABLE TO CONFIRM AN OCCLUSION AT THE JOINT TUBING AND MALE LUER. THE ROOT CAUSE OF THE OCCLUSION WAS DETERMINED TO BE AN EXCESS OF SOLVENT DUE TO MULTIPLE TUBE IMMERSION IN THE SOLVENT DISPENSER. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 10011865 BECAUSE A LOT NUMBER IS UNKNOWN. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET LINE WAS CONTINUALLY ALARMING OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INITIAL INFUSION SET-UP, THE LINE WAS CONTINUALLY ALARMING FOR OCCLUSION. UPON INVESTIGATION, DISCOVERED THAT THE 1.2 -MICRON FILTER ATTACHED TO THE LINE WOULD NOT FLUSH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET LINE WAS CONTINUALLY ALARMING OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INITIAL INFUSION SET-UP, THE LINE WAS CONTINUALLY ALARMING FOR OCCLUSION. UPON INVESTIGATION, DISCOVERED THAT THE 1.2-MICRON FILTER ATTACHED TO THE LINE WOULD NOT FLUSH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET LINE WAS CONTINUALLY ALARMING OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INITIAL INFUSION SET-UP, THE LINE WAS CONTINUALLY ALARMING FOR OCCLUSION. UPON INVESTIGATION, DISCOVERED THAT THE 1.2-MICRON FILTER ATTACHED TO THE LINE WOULD NOT FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2919403 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10011865 UNKNOWN 50885403233645

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown