BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMSA M60 PRE SET

    MDR report key: 3131285 · Received April 9, 2006

    Report

    Report Number
    8010182-2006-00011
    Event Type
    Other
    Date Received
    April 9, 2006
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REVIEW OF OUR COMPLAINT FILE INDICATED THAT IT IS THE FIRST TIME THIS TYPE OF EVENT IS REPORTED ON THE PRISMA M60 PRESET LOT 06C2279P. THE INCRIMINATED SAMPLE WAS REQUESTED FOR INVESTIGATION (NOT YET RECEIVED). FOR THAT REASON, THE PRESET REPORT IS AN INITIAL REPORT THAT WILL BE COMPLETED WITH A FOLLOW-UP REPORT AFTER INVESTIGATION. PATIENT'S AND THIRD PARTY'S RISK ANALYSIS: THE ACCESS POD IS WORKING UNDER NEGATIVE PRESSURE DURING TREATMENT. IN THESE CONDITIONS, THERE IS NO POSSIBILITY THAT A RUPTURE OF THE POD LEAD TO AN EXTERNAL BLOOD LEAK. DURING UNLOADING OF THE SET FROM THE MACHINE, THE PRESSURE BECOMES POSITIVE IN THE ACCESS POD BECAUSE THE PUMP IS ROTATING COUNTER CLOCKWISE. THE PRELIMINARY INVESTIGATION OF THIS COMPLAINT LED US TO CONCLUDE THAT THE OVERPRESSURE IN THE EXTRA-CORPOREAL BLOOD CIRCUIT, IN COMBINATION WITH EITHER AN INSUFFICIENT WELDING OF THE POD, OR A MEMBRANE RUPTURE, RESULTED IN THE EXTERNAL BLOOD LEAK REPORTED BY COMPLAINANT. WE CONSIDERED THERE WAS NO PATIENT'S SAFETY ISSUE BECAUSE THE INCIDENT OCCURRED DURING UNLOADING OF THE PRISMA SET, AFTER DISCONNECTION OF THE PATIENT, WHICH MEANS AT THE END OF THE TREATMENT. HOWEVER, EVEN IF THIS INCIDENT DID NOT REPRESENT A RISK FOR THE PATIENT, IT COULD HAVE PRESENTED A RISK OF INFECTION/CONTAMINATION FOR THE NURSE, DUE TO THE CONTACT WITH THE EXTERNAL BLOOD LEAK. FOR THIS REASON, WE DECIDED TO REPORT THIS CASE AS AN MDR. POSSIBLE ROOT CAUSE: PRELIMINARY INVESTIGATION ALLOWED US TO CONCLUDE THAT THE EXCESSIVE FRAGILITY OF THE PODS COMES FROM A POOR/INSUFFICIENT WELDING OF THE RETAINER TO THE BODY OF THE POD. CORRECTIVE ACTIONS: ACTIONS OF (B)(4) 2005 FROM PRISMA M60 LOT 05J2796P: 100% MEASUREMENT OF THE GAP EXISTING BETWEEN THE BODY AND THE RETAINER OF THE POD, AFTER WELDING. THE REVIEW OF THE COMPLAINT TRENDING HAS DEMONSTRATED A SIGNIFICANT DECREASE OF OCCURRENCE OF SUCH EVENTS. FURTHER IMPROVEMENT: IMPLEMENTATION OF A 100% AIR INTEGRITY TEST OF THE PODS UNDER 3 BARS, IN (B)(4) 2006. THE PODS TESTED UNDER THESE NEW CONDITIONS WILL BE IN USE IN THE FINISHED PRODUCTS FROM (B)(4) 2006. INVESTIGATION REPORT: WILL BE PROVIDED IN A FOLLOW-UP REPORT, AFTER INVESTIGATION OF THE INCRIMINATED SAMPLE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMSA M60 PRE SET PRISMA M60 PRESET KDI GAMBRO INDUSTRIES

    Patients

    Seq Age Sex Outcome Treatment
    1