BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    MDR report key: 8088344 · Received November 20, 2018

    Report

    Report Number
    9680841-2018-00031
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 26, 2018
    Report Date
    January 10, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE BMR 1900 PHISIO CLOSED VENOUS RESERVOIR BAG. THE INCIDENT OCCURRED IN AMSTERDAM-ZUIDOOST, NETHERLANDS. 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 INVOLVED BAG WAS RETURNED TO SORIN GROUP ITALIA WITH THE CONNECTOR COMPLETELY DETACHED. THE TUBE WAS RECONNECTED WITHOUT ADDITIONAL BONDING AND A LEAK TEST WAS PERFORMED BY FILLING THE BAG, MOUNTING IT ON THE DEDICATED BRACKET AND PRESSURIZING THE BAG TO 0.1 BAR FOR 15 MINUTES. THE LEAK TEST CONFIRMED A LEAK BETWEEN THE TUBE AND THE CONNECTOR OF THE INLET LINE. NO DISCONNECTION WAS OBSERVED. A REVIEW OF THE DHR DID NOT REVEAL ANY RELEVANT INFORMATION POSSIBLY LINKED WITH THE CLAIMED DEFECT. INVESTIGATION SUGGESTED THAT THE ROOT CAUSES OF THE REPORTED LEAK WERE A SMALL DEFORMATION OF THE TUBE AND A NON-HOMOGENEOUS DISTRIBUTION OF SOLVENT AT THE LEAKING POINT. ALTHOUGH THE FREQUENCY OF THIS TYPE OF EVENT IS VERY LOW AND THE RISK ASSOCIATED IS LOW, SORIN GROUP ITALIA ADJUSTED THE TOOL USED TO ENLARGE THE TUBE DURING THE INSERTION OF THE CONNECTOR TO PREVENT POSSIBLE TUBING DEFORMATION DURING MANUFACTURING. IN ADDITION, SORIN GROUP ITALIA HAS BEGUN PERFORMING IN-PROCESS PEEL TESTING BEFORE BATCH RELEASE. CORRECTIVE ACTIONS HAVE ALSO BEEN INITIATED TO EVALUATE IMPLEMENTATION OF ADDITIONAL MITIGATION.

    Additional Manufacturer Narrative · 0

    THE BMR 1900 PHISIO CLOSED VENOUS RESERVOIR BAG IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN00573, LOT 1805070154) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE BAG 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 BMR 1900L PHISIO BAG IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE BAG (CATALOG NUMBER 969000023) IS REGISTERED IN THE USA (510(K) NUMBER: K112771). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE BAG WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE BMR 1900 PHISIO CLOSED VENOUS RESERVOIR BAG. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, SORIN GROUP (B)(4). IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP (B)(4) (MANUFACTURER) AND (B)(4). (IMPORTER). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT DURING PRIMING, THE VENOUS IN-LET CONNECTOR GOT DISCONNECTED FROM THE BMR1900 BAG. THE ISSUE OCCURRED BEFORE USE, DURING PRIMING. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928204 BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA SRL 00397 1802200146

    Patients

    Seq Age Sex Outcome Treatment
    1