BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT FLOW SIPAP

    MDR report key: 4945153 · Received July 24, 2015

    Report

    Report Number
    2021710-2015-01257
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 26, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K031745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS (FA) LAB RECEIVED FAULTY FLOW METERS. DURING ADJUSTMENT, THE FLOW METER JUMPS READINGS MAKING IT IMPOSSIBLE TO GET CERTAIN SETTINGS. DURING VISUAL INSPECTION OF THE FLOW METER ITSELF, THE TUBING THAT CAME WITH IT DOES HAVE DISCOLORATION. THIS IS DUE TO SOME SORT OF LIQUID SUBSTANCE THAT CAN GET INTO THE METER ITSELF AND CAUSE THESE ABNORMALITIES. THE FAULTY FLOW METERS ALONG WITH OTHER FIXTURES AND TUBING WERE SCRAPPED.

    Additional Manufacturer Narrative · 1

    CAREFUSION TECHNICAL SUPPORT SHIPPED THE DISTRIBUTOR A REPLACEMENT FLOW METER, POLYURETHANE TUBE, CONNECTOR, AND SWIVEL ELBOW. A RETURN GOODS AUTHORIZATION (RGA) NUMBER WAS ALSO ISSUED FOR THE RETURN OF THE ALLEGED FAULTY PARTS FOR EVALUATION. THE ALLEGED FAULTY PARTS WERE RECEIVED ON JULY 17, 2015 AND WERE ROUTED TO CAREFUSION FAILURE ANALYSIS LAB FOR EVALUATION. AS OF JULY 24, 2015, EVALUATION IS ANTICIPATED, BUT IT HAS NOT BEGAN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT ORIGINATED FROM AN INTERNATIONAL DISTRIBUTOR IN (B)(4). THE DISTRIBUTOR REPORTED THAT IT IS DIFFICULT TO SET FLOW ON THE CPAP FLOW METER, BECAUSE THE FLOAT DOES NOT STABILIZE. THE DISTRIBUTOR EVALUATED THE UNIT AND FOUND THAT THERE WAS OIL IN THE TUBE OF CPAP FLOW METER AND WATER TRAP. ACCORDING TO THE DISTRIBUTOR, THIS ISSUE OCCURRED WITHIN A YEAR AFTER THE UNIT WAS DELIVERED TO THE HOSPITAL. THEY REQUESTED REPLACEMENT PARTS, AND OFFERED TO RETURN THE ALLEGED FAULTY PARTS. THE DISTRIBUTOR DID NOT INDICATE WHETHER THERE WAS ANY PATIENT INVOLVEMENT DURING THIS INCIDENT.

    Description of Event or Problem · 1

    ON 24 MAY, 2016, ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER REGARDING PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483250 INFANT FLOW SIPAP VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION SIPAP NA

    Patients

    Seq Age Sex Outcome Treatment
    1