This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite instrument, serial number (b)(4).Complaint number (b)(4) captures the child case for the lot number of the jact+ cuvette used during the procedure.Method: testing of actual/suspected device.Analysis of production records.Results: no device problem found.Analysis of production records did not show a history of repairs, non-conformities, capa, or other related complaints.Conclusion: no problem detected.Accriva diagnostics has requested all data required for form 3500a.This report serves as the initial and final mdr for this case and effectively closes the complaint.
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A healthcare professional reported inconsistent act results when 2 hemochron signature elite and act+ whole blood microcoagulation systems were run side-by-side during open heart surgery.The target act for this procedure was >420 seconds.After an intravenous bolus dose of heparin was given, the first 2 act readings with the elite named in this complaint were below the act target and were lower than expected.The act readings for the same 2 blood samples tested on a second hemochron signature elite and act+ microcoagulation system were 517 and 570 seconds, respectively.These results were above the target act and were used for patient management.The procedure was completed successfully and no adverse events were reported.Both electronic and liquid quality controls passed on both elite systems prior to the procedure.
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