BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 6072158 · Received November 2, 2016

    Report

    Report Number
    9680841-2016-00512
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 4, 2016
    Report Date
    February 21, 2017
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED FROM DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). (B)(4) THE BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM. THE INCIDENT OCCURRED IN (B)(6). AS PER EXPEMPTION NUMBER (B)(4), SORIN GROUP (B)(4) IS SUBMITTING FOLLOW-UP REPORT FOR BOTH (B)(4). EXPEMPTION NUMBER E2016005. ON OCTOBER 20, 2016, SORIN GROUP USA RECEIVED THE BCD VANGUARD FOR EVALUATION. VISUAL INSPECTION IDENTIFIED WAX BONE ONTO THE TOP VALVE OF THE DEVICE. SIMULATED USE TESTING COULD NOT BE PERFORMED DUE TO THE PRESENCE OF BONE WAX ON THE TOP VALVE. A DHR VERIFICATION DID NOT HIGHLIGHT ANY RELEVANT INFORMATION REGARDING THE REPORTED ISSUE. DURING MANUFACTURING, 100% OF BCD VANGUARD UNITS ARE TESTED TWICE FOR CORRECT FUNCTIONALITY OF THE TOP VALVE. AS THE DEVICE COULD NOT BE TESTED AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, DESPITE THE LOW DEFECT RATE FOR THIS TYPE OF ISSUE, SORIN GROUP (B)(4) INITIATED A CAPA TO IDENTIFY THE ROOT CAUSE. THE CAPA INVESTIGATION FOUND THAT THIS TYPE OF PROBLEM IS LIKELY RELATED TO A NON-PERFECTLY SEATED TOP VALVE. ACCORDING TO TRACEABILITY, THE CLAIMED UNIT HAS BEEN MANUFACTURED PRIOR THE IMPLEMENTATION OF THE CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE BCD VANGAURD (ITEM 050229, LOT NUMBER 1603220029) IS A NON-STERILE DEVICE THAT WAS ASSEMBLED INTO A CONVENIENCE PACK (CATALOG 084103204, LOT 1610500034) AND STERILIZED BEFORE DISTRIBUTION AND USE IN THE USA. EXPIRATION DATE (MM/DD/YYYY) OF CONVENIENCE PACK: 04/30/2018. (B)(4). DEVICE MANUFACTURE DATE (MM/DD/YYYY) OF THE CONVENIENCE PACK: 04/14/2016. THE SORIN BIOMEDICA SMARXT BCD VANGUARD WAS ASSEMBLED INTO A CONVENIENCE PACK DISTRIBUTED IN THE USA. THE NON-STERILE CARDIOPLEGIA HEAT EXCHANGER IS ALSO DISTRIBUTED IN THE USA (510(K)NUMBER: K021830). SORIN GROUP (B)(4) MANUFACTURES THE SORIN BIOMEDICA SMARXT BCD VANGUARD. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). ACCORDING TO TECHNICAL DOCUMENTATION OF THE CONVENIENCE PACK INTO WHICH THE CARDIOPLEGIA UNIT WAS ASSEMBLED, THE TRANSDUCER IS NOT INCLUDED IN THE PACK. 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 AIR WAS PULLED INTO THE TOP CAP OF THE VANGUARD BLOOD CARDIOPLEGIA SYSTEM DURING A PROCEDURE. THE MEDICAL TEAM ELECTED TO CHANGE THE TRANSDUCERS AND WERE ABLE TO COMPLETE THE CASE WITHOUT CHANGING THE CARDIOPLEGIA UNIT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722875 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM CARDIOPLEGIA HEAT EXCHANGER DTR SORIN GROUP ITALIA SRL 1601210101

    Patients

    Seq Age Sex Outcome Treatment
    1