BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 5048904 · Received August 27, 2015

    Report

    Report Number
    9680841-2015-00318
    Event Type
    Other
    Date Received
    August 27, 2015
    Date of Event
    July 28, 2015
    Report Date
    February 28, 2017
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    PMA / PMN Number
    K112771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE BMR1900 THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORTS IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE OUTLET CONNECTOR OF A BMR1900 BROKE OFF WHILE REMOVING IT FROM THE BRACKET DURING PRIMING. THERE WAS NO PT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE BMR 1900. THE INCIDENT OCCURRED IN (B)(6). (B)(4). THE COMPLAINED UNIT WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. VISUAL INSPECTION CONFIRMED THAT THE BLOOD OUTLET CONNECTOR WAS COMPLETELY BROKEN OFF. SIMULATED USE TESTING SUGGESTED THAT THE FORCE TO INDUCE BREAKAGE IS SIGNIFICANTLY HIGHER THAN THE NORMAL FORCE APPLIED TO SET-UP AND TEAR-DOWN THE BAG 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 WAS 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 INITIATED TO GUARANTEE CORRECT DISTRIBUTION OF THE SOLVENT BY INTRODUCING A SEMI-AUTOMATIC EQUIPMENT TO AVOID EXCESSIVE DISTRIBUTION OF THE BONDING AGENT. THE INVOLVED UNIT WAS MANUFACTURED BEFORE IMPLEMENTATION OF THE ABOVE CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE OUTLET CONNECTOR OF A BMR1900 BROKE OF WHILE REMOVING IT FROM THE BRACKET DURING PRIMING. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570731 BMR1900 PH, I. S. I. O. VENOUS RESERVOIR BAG RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA NA 1504160088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA