BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEBRA SEALITE TUBE SEALER POWER SOURCE

    MDR report key: 3121618 · Received May 17, 2013

    Report

    Report Number
    1219343-2013-00046
    Event Type
    Death
    Date Received
    May 17, 2013
    Date of Event
    November 1, 2011
    Report Date
    April 18, 2013
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    GKT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF HAEMONETICS COMPLAINT RECORDS SHOWED THAT THERE HAVE BEEN NO OTHER REPORTS FROM THIS CUSTOMER, OR REPORTS FROM ANY OTHER CUSTOMERS FOR THIS ISSUE. THERE ARE ALSO NO SIMILAR REPORTS OF CONTAMINATION RESULTING FROM USE WITH THE SEBRA DEVICE FROM ANY SOURCES.

    Description of Event or Problem · 1

    HAEMONETICS WAS CONTACTED ON (B)(6) 2013 VIA E-MAIL FROM A FORMER DISTRIBUTOR, (B)(4). THEY HAD RECEIVED CORRESPONDENCE FROM (B)(6) IN REGARDS TO A CUSTOMER REPORT THEY HAD RECEIVED. THIS REPORT WAS STATING A PROBLEM THAT THE CUSTOMER ENCOUNTERED WHILE USING THE SEBRA 2490 DEVICE. THE REPORT FILED WITH (B)(6) STATED THAT THE CUSTOMER HAD AN EVENT WITH CONTAMINATED THROMBOCYTES WHICH RESULTED IN A PT DEATH. THE SEBRA WAS USED AT SOME POINT IN TIME ON THE TUBING ASSOCIATED WITH THE COLLECTED THROMBOCYTES. THE CUSTOMER STATES THEY EXPERIENCED AN ISSUE WITH SEALING; HOWEVER, THE SEBRA 2490 PRODUCT LIST NUMBER IS ASSOCIATED WITH A SEALITE TUBE SEALER POWER SOURCE. NO SERIAL NUMBER OR CLINICAL INFORMATION WAS KNOWN OR PROVIDED BY THE DISTRIBUTOR OR OBTAINABLE AFTER THREE GOOD FAITH EFFORT ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219531 SEBRA SEALITE TUBE SEALER POWER SOURCE GKT HAEMONETICS CORP. 2490

    Patients

    Seq Age Sex Outcome Treatment
    1 Death