BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 6107548 · Received November 16, 2016

    Report

    Report Number
    9680841-2016-00515
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 17, 2016
    Report Date
    February 21, 2017
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM. THE INCIDENT OCCURRED IN (B)(4). AS PER EXEMPTION NUMBER (B)(4). SORIN GROUP (B)(4) IS SUBMITTING FOLLOW-UP REPORT FOR BOTH SORIN GROUP (B)(4) (MANUFACTURER) AND (B)(4). THE BCD VANGUARD HEAT EXCHANGER WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. EXPEMPTION NUMBER E2016005. VISUAL INSPECTION OF THE DEVICE DID NOT REVEAL ANY DEFECTS. SIMULATED USE TESTING WAS NOT ABLE TO REPLICATE THE REPORTED DEPRIMING ISSUE. HOWEVER, LEAK TESTING IDENTIFIED A FLUID LEAK FROM THE TOP CAP OF THE DEVICE. FLUID INFILTRATION IN THAT ZONE SHOULD NOT BE ALLOWED DUE TO A HYDROPHOBIC MEMBRANE WHICH SEPARATES TOP CHAMBER INTO TWO COMPARTMENTS. THE LEAK COULD BE CAUSED BY AN ISSUE IN THE MEMBRANE. A DHR REVIEW 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. THE REPORTED DEPRIMING ISSUE IS NOT ALWAYS REPRODUCIBLE DUE TO MOVEMENT OF THE TOP VALVE. SORIN GROUP (B)(4) CANNOT EXCLUDE THAT THE DEPRIMING REPORTED BY THE CUSTOMER WAS INITIALLY CAUSED BY THE LEAK ACROSS THE HYDROPHOBIC MEMBRANE, WHICH CAN DISPLACE THE TOP VALVE FROM ITS CORRECT POSITION. DESPITE THE LOW DEFECT RATE FOR THIS TYPE OF ISSUE, SORIN GROUP (B)(4) INITIATED A CAPA TO IDENTIFY THE ROOT CAUSE FOR DEPRIMING. THE CAPA INVESTIGATION CONCLUDED THAT THIS TYPE OF PROBLEM IS LIKELY RELATED TO A NON-PERFECTLY SEATED TOP VALVE. AS THE EVENT DATE WAS PRIOR TO THE CAPA CLOSURE, IT IS LIKELY THAT THE CONVENIENCE PACK WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE BCD VANGAURD (ITEM 050229, LOT NUMBER 1602260145) IS A NON-STERILE DEVICE THAT WAS ASSEMBLED INTO CONVENIENCE PACK CATALOG NUMBER 044003200 AND STERILIZED BEFORE DISTRIBUTION AND USE IN THE USA. THE COMPLAINED LOT OF BCD VANGAURDS WAS ASSEMBLED INTO MULTIPLE LOTS OF CONVENIENCE PACK 044003200, SO THE LOT NUMBER IS UNKNOWN. EXPIRATION DATE (MM/DD/YYYY) OF CONVENIENCE PACK: AS THE LOT IS UNKNOWN, THE EXPIRATION DATE COULD NOT BE DETERMINED. DEVICE IDENTIFIER (DI) NUMBER FOR THE CONVENIENCE PACK: 00803622111938. DEVICE MANUFACTURE DATE (MM/DD/YYYY) OF THE CONVENIENCE PACK: AS THE LOT NUMBER IS UNKNOWN, THE MANUFACTURE DATE COULD NOT BE DETERMINED. 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). 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 AND THE UNIT EMPTIED WHEN IT WAS EXPOSED TO A MILD NEGATIVE PRESSURE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756527 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM CARDIOPLEGIA HEAT EXCHANGER DTR SORIN GROUP ITALIA SRL 1602260145

    Patients

    Seq Age Sex Outcome Treatment
    1