BEUDAMED
    FDA Adverse Event Summary report: N

    SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 6064104 · Received October 28, 2016

    Report

    Report Number
    9680841-2016-00511
    Date Received
    October 28, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 30, 2016
    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 · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE BCD VANGUARD (ITEM 050229, LOT NUMBER 1603220029) IS A NON-STERILE DEVICE THAT WAS ASSEMBLED INTO A CONVENIENCE PACK AND STERILIZED BEFORE DISTRIBUTION AND USE IN THE USA. THE CATALOG NUMBER FOR THE PACK IS 084103204, HOWEVER THE LOT NUMBER IS UNCLEAR. TWO LOT NUMBERS WERE REPORTED (1610500034 AND 1616700028), AND IT IS UNKNOWN WHICH PACK THIS BCD VANGUARD DEVICE WAS ASSEMBLED INTO. EXPIRATION DATE (MM/DD/YYYY) FOR CONVENIENCE PACKS: LOT 1616700028 - 06/30/2018, LOT 1610500034 - 04/30/2018. UNIQUE IDENTIFIER (UDI) NUMBER FOR THE CONVENIENCE PACKS: LOT 1616700028 - (B)(4), LOT 1610500034 - (B)(4). THE SORIN BIOMEDICA SMARXT BCD VANGUARD WAS ASSEMBLED INTO A CONVENIENCE PACK DISTRIBUTED IN USA. THE NON-STERILE CARDIOPLEGIA HEAT EXCHANGER IS ALSO DISTRIBUTED IN THE USA (510(K)NUMBER: K021830). DEVICE MANUFACTURE DATE (MM/DD/YYYY) FOR THE CONVENIENCE PACKS: LOT 1616700028 - 06/15/2016, LOT 1610500034 - 04/14/2016. (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). SORIN GROUP (B)(4) RECEIVED A REPORT THAT AIR WAS PULLED INTO THE TOP CAP OF THE VANGUARD BLOOD CARDIOPLEGIA SYSTEM WHERE THE VALVE IS. THERE WAS NO REPORT OF PATIENT INJURY. AS NO DEVICE WAS MADE AVAILABLE FOR RETURN TO SORIN GROUP (B)(4), PHYSICAL INVESTIGATION OF THE UNIT WAS NOT POSSIBLE. PER THE COMPLAINT DESCRIPTION, THE EVENT THAT OCCURRED AT THE CUSTOMER SITE WAS AIR INTAKE INTO THE UNIT DUE TO THE UMBRELLA VALVE ON TOP OF THE UNIT NOT FUNCTIONING CORRECTLY. A DHR VERIFICATION DID NOT HIGHLIGHT ANY RELEVANT INFORMATION REGARDING THE REPORTED ISSUE. DURING PRODUCTION, 100% OF BCD VANGUARD UNITS ARE TESTED TWICE (IN TWO DIFFERENT STEPS OF MANUFACTURING) FOR CONFORMANCE OF THE FUNCTIONALITY OF THE UMBRELLA VALVE. TRACEABILITY OF THE COMPLAINED UNIT (FINISHED PRODUCTS AND RAW MATERIALS) DID NOT IDENTIFY A ROOT CAUSE. SORIN GROUP (B)(4) HAS CONCLUDED THAT THE PROBLEM MAY BE RELATED TO A NON-PERFECTLY SEATED UMBRELLA VALVE. AS THE DEVICE WAS NOT RETURNED, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. DESPITE THE LOW DEFECT RATE FOR THIS TYPE OF ISSUE, SORIN GROUP (B)(4) HAS OPENED A CAPA TO IDENTIFY THE ROOT CAUSE FOR THIS ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR REPORTS FOR THIS TYPE OF ISSUE. DEVICE NOT AVAILABLE FOR RETURN.

    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 WHERE THE VALVE IS. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714266 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM HEAT-EXCHANGER, CARDIOPULMONARY BYPASS DTR SORIN GROUP ITALIA SRL 1601210101

    Patients

    Seq Age Sex Outcome Treatment
    1