BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE

    MDR report key: 7689122 · Received July 16, 2018

    Report

    Report Number
    9680841-2018-00018
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 10, 2018
    Report Date
    October 23, 2018
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WAS NOT INVOLVED. THE D131 DIDECO KIDS INFANT ARTERIAL FILTER IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (LOT 1511090048) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE ARTERIAL FILTER WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). THE COMPLAINED D131 DIDECO KIDS INFANT ARTERIAL FILTER IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE ARTERIAL FILTER (CATALOG NUMBER 050542) IS REGISTERED IN THE USA. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE ARTERIAL FILTER WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE D131 DIDECO KIDS INFANT ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS MDR HAS BEEN ALREADY SUBMITTED JULY 10, 2018 AND RESUBMITTED DUE TO MISSING 3RD ACKNOWLEDGMENT. DEVICE NOT AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE D131 DIDECO KIDS INFANT ARTERIAL FILTER. THE INCIDENT OCCURRED IN KHARTOUM, SUDAN. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). THE DEVICE WAS DISCARDED BY THE USER. BASING ON A PHOTOGRAPH PROVIDED BY THE CUSTOMER, THE FILTER OUTLET CONNECTOR WAS CONFIRMED TO BE BROKEN AT THE BASE OF THE CONNECTOR ITSELF. A REVIEW OF THE PRODUCTION HISTORY CONFIRMED THAT THE REPORTED ARTERIAL FILTER LOT WAS USED FOR THE MANUFACTURING OF NUMEROUS OTHER CIRCUITS THAT WERE DISTRIBUTED ALL OVER THE WORLD. AS OF TODAY, SORIN GROUP ITALIA HAS NOT RECEIVED ANY ADDITIONAL REPORTS CONCERNING THE REPORTED LOT. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. AS THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION, A ROOT CAUSE COULD NOT BE ESTABLISHED. HOWEVER, BASED ON THE INVESTIGATION FOR PREVIOUSLY REPORTED SIMILAR EVENTS, THE POTENTIAL CAUSE OF THE EVENT WAS DETERMINED TO BE THE RELEASE OF MOLD-IN STRESSES ENHANCED BY SHIPPING TRANSPORTATION STRESSES.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE BLOOD OUTLET CONNECTOR OF THE D131 ARTERIAL FILTER COMPLETELY BROKE OFF DURING SET-UP. THE ISSUE OCCURRED PRIOR TO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534165 D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM SORIN GROUP ITALIA 1510060162

    Patients

    Seq Age Sex Outcome Treatment
    1