BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5523948 · Received March 24, 2016

    Report

    Report Number
    9680841-2016-00163
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 2, 2016
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE BMR 1900 L PHISIO. 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 THE OUTLET CONNECTOR OF THE VENOUS RESERVOIR BMR 1900 L PHISIO BROKE OFF FOLLOWING A PROCEDURE. AS THE EVENT OCCURRED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINED UNIT WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION WHERE IT UNDERWENT VISUAL INSPECTION. THE INSPECTION FOUND THAT THE BREAKAGE OF THE CONNECTOR SEEMED TO OCCUR AS A RESULT OF AN UNUSUAL TEAR-DOWN OPERATION DONE IN AN ORTHOGONAL DIRECTION WITH RESPECT TO THE BACKPLATE. USE SIMULATION SUGGESTED THAT THE FORCE TO INDUCE BREAKAGE IS SIGNIFICANTLY HIGHER THAN THE NORMAL FORCE APPLIED TO SET-UP AND TEAR-DOWN THE BAG TO AND FORM THE BRACKET. IN ORDER TO IMPROVE THE RESISTANCE OF THE CONNECTORS TO MECHANICAL STRESS, A CAPA WAS INITIATED AND THE LENGTH OF THE PVC TUBING HAS BEEN INCREASED BY 4MM. THIS CHANGE PERMITS A REDUCTION OF THE PULL FORCE TO BE APPLIED TO THE CONNECTORS DURING THE SET-UP AND TEAR-DOWN OF THE BAG WITHOUT IMPACTING THE POSITIONING OF THE BAG ONTO THE BRACKET. AN ADDITIONAL CAPA WAS ALSO INITIATED TO GUARANTEE A CORRECT DISTRIBUTION OF THE SOLVENT DURING THE GLUING PHASE. TO ACHIEVE THIS, A SEMI-AUTOMATIC EQUIPMENT WHICH AVOIDS EXCESSIVE DISTRIBUTION OF THE BONDING AGENT WAS INTRODUCED IN THE MANUFACTURING AREA IN MARCH, 2016. THE INVOLVED UNIT WAS MANUFACTURED BEFORE IMPLEMENTATION OF THE ABOVE CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. AT THE DATE OF THE PRESENT REPORT, THE UNIT HAS NOT BEEN RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. THE BMR 1900 L PHISIO WAS ASSEMBLED INTO A CUSTOMIZED PRODUCT (CATALOG NUMBER IN00197) THAT IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE BMR 1900 L PHISIO VENOUS RESERVOIR BAG (CATALOG NUMBER 00398), WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K112771). SORIN GROUP (B)(4) MANUFACTURES THE BMR 1900 L PHISIO. 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 THE OUTLET CONNECTOR OF THE VENOUS RESERVOIR BMR 1900 L PHISIO BROKE OFF FOLLOWING A PROCEDURE. AS THE EVENT OCCURRED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE OUTLET CONNECTOR OF THE VENOUS RESERVOIR BMR 1900 L PHISIO BROKE OFF FOLLOWING A PROCEDURE. AS THE EVENT OCCURRED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179840 BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA 1511120026

    Patients

    Seq Age Sex Outcome Treatment
    1