BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6348393 · Received February 22, 2017

    Report

    Report Number
    9680841-2017-00004
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    January 25, 2017
    Report Date
    May 5, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (B)(4) MANUFACTURES THE BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAGS. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. (B)(4). TWO DEVICES WERE RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. VISUAL INSPECTION OF THE ONE OF THE DEVICES REVEALED THAT THE OUTLET CONNECTOR WAS COMPLETELY DETACHED. NO TRACE OF ADHESIVE WAS VISIBLE. THE CONNECTOR OF THE SECOND DEVICE WAS CONNECTED. THIS DEVICE WAS LEAK TESTED AND NO LEAKS WERE OBSERVED. BASED ON THE RESULTS OF THE INVESTIGATION, SORIN GROUP (B)(4) BELIEVES THAT THE MOST PROBABLE ROOT CAUSE OF THE CONNECTOR DETACHMENT IS AN INCOMPLETE GLUING PROCESS DURING MANUFACTURING. THE RELEVANT MANUFACTURING FLOOR PERSONNEL HAVE BEEN MADE AWARE OF THE EVENT TO PREVENT RECURRENCE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATION OR NON-CONFORMITY RELEVANT TO THE REPORTED ISSUE. NO SIMILAR COMPLAINTS RELATED TO THIS LOT HAVE BEEN REPORTED. THIS EVEN IS CONSIDERED TO BE AN ISOLATED INCIDENT.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. THE BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAGS (ITEM 00398, LOT NUMBER 1605250167) ARE NON-STERILE DEVICES THAT ARE ASSEMBLED INTO CONVENIENCE PACKS FOR STERILIZATION AND DISTRIBUTION IN THE USA. THE LOT NUMBER OF THE CONVENIENCE PACK WAS NOT REPORTED BY THE CUSTOMER, SO THE EXPIRATION DATE AND DEVICE IDENTIFIER (UDI) NUMBER COULD NOT BE DETERMINED. HOWEVER, THE CUSTOMER REPORTED THAT THE BAGS BELONGED TO THE SAME LOT OF CONVENIENCE PACK. APPROXIMATE AGE OF DEVICE: AS THE MANUFACTURING DATE OF THE CONVENIENCE PACK CANNOT BE DETERMINED, THE APPROXIMATE AGE OF DEVICE COULD NOT BE DETERMINED (B)(4). THE BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAGS WERE ASSEMBLED INTO A CONVENIENCE PACKS DISTRIBUTED IN THE USA. THE NON-STERILE THE BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG IS ALSO DISTRIBUTED IN THE USA (510(K) NUMBER: K112771). AS THE LOT NUMBER HAS NOT BEEN PROVIDED, THE DEVICE MANUFACTURE DATE IS UNKNOWN. SORIN GROUP (B)(4) MANUFACTURES THE BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAGS. THE INCIDENT OCCURRED IN (B)(6). (B)(4). PER EXEMPTION NUMBER E2016005. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATION OR NON-CONFORMITY RELEVANT TO THE REPORTED ISSUE. THE DEVICES HAVE BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETE. DEVICE NOT YET RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE BMR1900 VENOUS RESERVOIR BAG LEAKED FROM THE OUTLET WHILE DISMOUNTING THE BAG DURING PRIMING. THE LEAK OCCURRED WHEN OUTLET CONNECTOR DETACHED FROM THE BAG. THE ISSUE REPORTEDLY OCCURRED TWICE, AND BOTH BAGS BELONGED TO THE SAME CONVENIENCE PACK LOT NUMBER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133559 BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA S.R.L. 00398 1605250167

    Patients

    Seq Age Sex Outcome Treatment
    1