BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER

    MDR report key: 5330989 · Received December 28, 2015

    Report

    Report Number
    9680841-2015-00632
    Event Type
    Malfunction
    Date Received
    December 28, 2015
    Date of Event
    December 2, 2015
    Report Date
    December 2, 2015
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    JOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILLED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE A LEAK WAS FOUND AT THE OUTPUT PORT OF THE D733 ARTERIAL FILTER DURING PRIMING. AS THE DEVICE WAS CHANGED OUT, THE BLOOD OUTPUT CONNECTOR COMPLETELY DETACHED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINED UNIT WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED FILTER REVEALED THAT THE BLOOD OUTLET PORT WAS BROKEN OFF AT THE BASE OF THE PORT, THOUGH NO SIGNIFICANT WHITENING OR DEFORMATION WAS OBSERVED IN THE MATERIAL AT THE BREAK SITE. CLOSER INSPECTION REVEALED THAT THE TUBING WAS INSERTED TO THE END OF THE PORT INSTEAD OF BEING INSERTED 2-3MM AWAY FROM THE BASE AS STATED IN THE ASSEMBLY PROCEDURE. THIS MISASSEMBLY CAN RESULT IN THE RELEASE OF RESIDUAL MOLD-IN STRESS THAT CAN CAUSE THE PORT TO BREAK. THE FREQUENCY OF OCCURRENCE FOR THIS EVENT IS VERY LOW (<0.001%). THE MANUFACTURING FLOOR HAS BEEN MADE AWARE OF THIS ISSUE. TO PREVENT RECURRENCE, A NEW TRAINING PROCEDURE WAS IMPLEMENTED TO PERIODICALLY SENSITIZE AND RETRAIN PERSONNEL REGARDING COMPLAINTS THAT ARE ATTRIBUTABLE TO ASSEMBLY ERRORS ON THE MANUFACTURING FLOOR. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Additional Manufacturer Narrative · 1

    AT THE DATE OF THE PRESENT REPORT, THE UNIT HAS NOT BEEN RETURNED TO THE MANUFACTURER FACILITIES FOR INVESTIGATION. THE ARTERIAL FILTER ITEM (B)(4) WAS ASSEMBLED INTO A CUSTOMIZED CIRCUIT THAT IS NOT DISTRIBUTED IN THE USA, BUT THE COMPLAINED DEVICE IS SIMILAR TO THE ARTERIAL FILTER D733, WHICH IS DISTRIBUTED IN THE USA (510K#: (B)(4)). SORIN GROUP (B)(4) MANUFACTURES THE D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILLED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE A LEAK WAS FOUND AT THE OUTPUT PORT OF THE D733 ARTERIAL FILTER DURING PRIMING. AS THE DEVICE WAS CHANGED OUT, THE BLOOD OUTPUT CONNECTOR COMPLETELY DETACHED. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE A LEAK WAS FOUND AT THE OUTPUT PORT OF THE D733 ARTERIAL FILTER DURING PRIMING. AS THE DEVICE WAS CHANGED OUT, THE BLOOD OUTPUT CONNECTOR COMPLETELY DETACHED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853427 D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE JOD SORIN GROUP ITALIA N/A 1508270013

    Patients

    Seq Age Sex Outcome Treatment
    1