BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUNTEER PERF KNOXVILLE TN1

    MDR report key: 4645000 · Received March 23, 2015

    Report

    Report Number
    1718850-2015-00075
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Date of Event
    February 24, 2015
    Report Date
    February 24, 2015
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CUSTOM PERFUSION PACK IS MFG BY SORIN GROUP USA INC. THE D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER IS MFG BY SORIN GROUP (B)(4) AND IS A COMPONENT OF THIS PACK. SORIN GROUP REC'D A REPORT THAT THE CLINICIAN WAS TAPPING THE ARTERIAL FILTER TO DEBUBBLE THE FILTER WHEN THE OUTLET PORT BROKE OFF DURING PRIMING. THERE WAS NO PT INVOLVEMENT. ONE D733 MICRO 40 ARTERIAL FILTER (B)(4) WAS RETURNED TO SGU FOR EVAL. UPON RECEIPT THE UNIT WAS SUBJECTED TO VISUAL INSPECTION. VISUAL INSPECTION CONFIRMED THE OUTLET PORT OF THE ARTERIAL FILTER HAD BROKEN OFF. THE TUBING AND OTHER PIECE OF THE OUTLET PORT WAS NOT RETURNED FOR EVAL. NO SIGNIFICANT WHITENING OR DEFORMATION WAS OBSERVED IN THE MATERIAL AT THE BREAK SITE. NO OTHER DEFECTS OR ABNORMALITIES WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD BY SORIN GROUP (B)(4) FOUND NO DEVIATIONS OR ABNORMALITIES RELATED TO THE REPORTED ISSUE. MFG RECORDS WERE VERIFIED AS CONFIRMING TO SPECIFICATION. ALTHOUGH THE ROOT CAUSE COULD NOT BE CONFIRMED, SORIN GROUP (B)(4) HAS CONCLUDED THAT THE ISSUE WAS MOST LIKELY CAUSED BY RESIDUAL MOLD-IN STRESS THAT CAS RELEASED WHEN SOLVENT WAS APPLIED TO THE TUBING ATTACHED TO THE OUTLET PORT AND THE TUBING COMPLETELY INSERTED ONTO THE PORT. SORIN GROUP USA HAS INITIATED A FORMAL CAPA PROJECT TO INVESTIGATE THE ROOT CAUSE FOR THE ISSUE AND IDENTIFY APPROPRIATE CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    SORIN GROUP REC'D A REPORT THAT THE CLINICIAN WAS TAPPING THE ARTERIAL FILTER TO DEBUBBLE THE FILTER WHEN THE OUTLET PORT BROKE OFF DURING PRIMING. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194539 VOLUNTEER PERF KNOXVILLE TN1 CUSTOM PERFUSION PACK DWE SORIN GROUP USA, INC. NA 1424700032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA