BEUDAMED
    FDA Adverse Event Summary report: N

    D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE

    MDR report key: 5408878 · Received February 3, 2016

    Report

    Report Number
    9680841-2016-00010
    Date Received
    February 3, 2016
    Date of Event
    December 18, 2015
    Report Date
    January 11, 2016
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    \PATIENT INFORMATION WERE NOT PROVIDED PMA 510(K): THE D131 DIDECO KIDS ARTERIAL FILTER WAS ASSEMBLED INTO A CUSTOMIZED CIRCUIT THAT IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE STERIL ARTERIAL FILTER THAT IS DISTRIBUTED IN THE USA (510(K) NUMBER: K072308). AT THE DATE OF THE PRESENT REPORT, THE UNIT HAS NOT BEEN RETURNED TO THE MANUFACTURER FACILITIES FOR INVESTIGATION. SORIN GROUP (B)(4) MANUFACTURES THE D131 DIDECO KIDS ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT, DURING PRIMING, THE D131 KIDS ARTERIAL FILTER WAS LEAKING PRIMING SOLUTION FROM THE WELDING LINE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. ON (B)(4), SORIN GROUP (B)(4) BECAME AWARE THAT THE USER FACILITY HAD SUBMITTED A REPORT TO THE LOCAL COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION. THE INVESTIGATION IS ON GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE D131 DIDECO KIDS ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT, DURING PRIMING, THE D131 KIDS ARTERIAL FILTER WAS LEAKING PRIMING SOLUTION FROM THE WELDING LINE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. ON JANUARY 11TH, SORIN GROUP (B)(4) BECAME AWARE THAT THE USER FACILITY HAD SUBMITTED A REPORT TO THE LOCAL COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION. DESPITE ATTEMPTS TO RETRIEVE ARTERIAL FILTER FROM THE CUSTOMER, THE DEVICE WAS NOT RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. WITHOUT THE ABILITY TO INVESTIGATE THE INVOLVED DEVICE, THE REPORTED ISSUE COULD NOT BE REPRODUCED AND A ROOT CAUSE AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED. HOWEVER, 100% OF THE ARTERIAL FILTERS ARE LEAK TESTED AT THE SAME CONDITIONS TO THOSE RECOMMENDED FOR THE USE OF THE DEVICE AS PART OF THE MANUFACTURING IN-PROCESS CONTROL. THE RECORDS FOR THE CONTROL IN PROCESS FOR THE COMPLAINED UNIT DID NOT HIGHLIGHT ANY DEVIATION OR NON-CONFORMITY TO THE LEAK TEST ACCEPTANCE CRITERIA. THE DEVICE WAS RELEASED COMPLIANT WITH THE SPECIFICATIONS. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR THIS TYPE OF ISSUE. CUSTOMER DID NOT RETURN.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4)RECEIVED A REPORT THAT THE D131 KIDS ARTERIAL FILTER LEAKED PRIMING SOLUTION FROM THE WELDING LINE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. ON (B)(4) SORIN GROUP BECAME AWARE THAT THE USER FACILITY HAD SUBMITTED A REPORT TO THE LOCAL COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67196 D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM SORIN GROUP ITALIA N/A 1407090072

    Patients

    Seq Age Sex Outcome Treatment
    1