BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/18 IN

    MDR report key: 7437714 · Received April 17, 2018

    Report

    Report Number
    3004365956-2018-00114
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    April 2, 2018
    Report Date
    April 3, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A MEDWATCH WAS RECEIVED FROM THE USER FACILITY - UF# (B)(4) PER MEDWATCH REPORT: FEMALE BABY 27 WEEK GESTATION 880 GRAMS; DIAGNOSED WITH PREMATURITY AND RESPIRATORY DISTRESS BEING VENTILATED, HOWEVER IT WAS REPORTED THAT THE INFANT WAS OFF THE VENTILATOR AT THE TIME OF THE REPORTED EVENT. ONE INSPIRATORY LEG OF THE INFANT BREATHING CIRCUIT WAS RECEIVED FOR INVESTIGATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CLEAR PLASTIC TEMPERATURE PROBE PORTAL WAS BROKEN. BASED ON A PRELIMINARY INVESTIGATION, THE BREAK IN THE TEMPERATURE PROBE PORTAL IS AT A SONIC WELD. THE PROBABLE CAUSE IS UNKNOWN AT THIS TIME. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. *A CONCLUSION CODE COULD NOT BE FOUND AS THE COMPLAINT WAS CONFIRMED; HOWEVER, A ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "THE CIRCUIT CONNECTION WHERE IT CONNECTS TO THE REMOTE TUBING FOR THE ISOLETTE CRACKED AND BROKE ." ALLEGED EVENT REPORTED AS OCCURRED DURING USE. IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE".

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. TWO PHOTOS OF CATALOG NUMBER 780-07 WERE RECEIVED FOR ANALYSIS. IT CAN BE OBSERVED THE TEE ADAPTOR IP-6234 BROKEN AS DESCRIBED IN THE COMPLAINT DESCRIPTION. NO OTHER ISSUES WERE OBSERVED. THE DEVICE HISTORY RECORD OF BATCH NUMBER 74D1700921 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. ALSO, THE DHR OF COMPONENT CODE IP-6234 WITH LOT NUMBER 2219459 WAS REVIEWED AND ONE PARAMETER WAS FOUND OUT OF TOLERANCE ACCORDING TO PARAMETER SHEET (B)(4) REV.00 FOR ULTRASONIC WELDER MACHINE. CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE VISUAL INSPECTION OF THE PHOTOGRAPHS SUBMITTED. ROOT CAUSE IS A PARAMETER OUT OF TOLERANCE. AN NC WAS OPENED TO FURTHER ADDRESS THE ISSUE OF TEE ADAPTOR IP-6234.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE CIRCUIT CONNECTION WHERE IT CONNECTS TO THE REMOTE TUBING FOR THE ISOLETTE CRACKED AND BROKE ." ALLEGED EVENT REPORTED AS OCCURRED DURING USE. IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278867 HUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/18 IN SET, TUBING AND SUPPORT,VENTILATOR BZO TELEFLEX MEDICAL 74D1700921

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA