BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMA

    MDR report key: 882397 · Received July 20, 2007

    Report

    Report Number
    8010182-2007-00004
    Event Type
    Death
    Date Received
    July 20, 2007
    Date of Event
    June 16, 2007
    Report Date
    June 18, 2007
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    FII
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE GUIDELINE ON MEDICAL DEVICE VIGILANCE/MEDICAL DEVICE REPORTING, WE TRANSMIT YOU AN INITIAL REPORT CONCERNING PRISMA SETS MANUFACTURED BY GAMBRO INDUSTRIES. THE MANUFACTURER OF THE PRISMA MONITOR RECEIVED A COMPLAINT ABOUT A PT DEATH WITH A POTENTIAL INVOLVEMENT OF THE PRISMA TREATMENT SYSTEM. INVESTIGATION AND ASSESSEMENT OF GAMBRO DASCO SPA ARE DESCRIBED IN THE VIGILANCE REPORTS MDR 9616240-2007-00071 AND 00072 AND A THIRD REPORT PROVIDED BY GAMBRO DASCO SPA. GAMBRO INDUSTRIES, THE MANUFACTURER OF THE PRISMA SETS WAS INFORMED ABOUT THE COMPLAINT BY GAMBRO SPA AND STARTED OWN INVESTIGATIONS AND ASSESSMENTS ON THE BATCH OF PRISMA SETS USED FOR THE SET UP OF THE TREATMENT SYSTEM. COMPLAINT INVESTIGATION: THE COMPLAINT DESCRIBES DIFFICULTIES OBSERVED DURING PRIMING OF PRISMA SETS FROM BATCH 07C3097G. COMPLAINT HISTORY FOR BATCH 07C3097G: WE RECEIVED COMPLAINTS RELATED TO PRIMING FOR THIS BATCH FROM THREE CUSTOMERS: ONE UNIT): NO SAMPLE WAS MADE AVAILABLE FOR INVESTIGATION, HOSPITAL (TWO UNITS): SAMPLES WERE AVAILABLE FOR INVESTIGATION, HOSPITAL (THREE UNITS): NO SAMPLE WAS MADE AVAILABLE FOR INVESTIGATION. COMPLAINTS RELATED TO PRIMING RECEIVED FOR OTHER BATCH NUMBERS (CALCULATED OVER THE LAST 12 MONTH PERIOD): THE OVERALL RATE OF COMPLAINTS RELATING TO PRIMING IS 1.06 PER 10,000 DEVICES. OF THE COMPLAINTS RECEIVED: 42% WERE RELATED TO MACHINES FOR WHICH THE INVESTIGATION DID NOT DEMONSTRATE ANY ANOMALY. 42% WERE INSUFFICIENTLY DOCUMENTED TO ENABLE US TO CONDUCT A THOROUGH INVESTIGATION. (MISSING INFORMATION, MISSING INCRIMINATED SAMPLE FROM THE COMPLAINANT) 16% WERE RELATED TO AN INCORRECT LOADING OF THE SET OF ON THE MACHINE, OR A BAD CONNECTION OF THE LINES TO THE RINSING BAGS. INVESTIGATION OF SAMPLES: WE RECEIVED SAMPLES FROM HOSPITAL AND PERFORMED AN INVESTIGATION IN OUR LABORATORY. NO DEFECTS WERE IDENTIFIED DURING THE PRIMING TESTS. IN PARTICULAR, THERE WERE NO LEAKS, NO PROBLEMS WITH THE AIR INTAKE AND NO ISSUES WITH THE ALARMS. THE SETS COULD BE PRIMED WITHOUT PROBLEM. THUS, THE DEVICES WERE CONFIRMED AS CONFORMING. DISTRIBUTION OF BATCH 07C3097G PRISMA SETS FROM THIS BATCH NUMBER WERE DISTRIBUTED IN TWO COUNTRIES. NO COMPLAINTS RELATED TO PRIMING WERE REPORTED FROM TWO COUNTRIES AND FROM ANOTHER COUNTRY, ONLY THE COMPLAINTS FROM THE 3 CUSTOMERS INDICATED ABOVE WERE RECEIVED. BASED ON THE COMPLAINT HISTORY AND THE RESULTS OF THE SAMPLE INVESTIGATION, WE DETERMINED THAT A LACK OF ADEQUATE TRAINING WAS A POSSIBLE CAUSE LEADING TO THE PRIMING PROBLEM. CONCLUSION: TAKING INTO ACCOUNT THE RATE OF COMPLAINTS INDICATED ABOVE, THE PROBABILITY THAT RECURRENT DEVICE FAILURES OR MALFUNCTIONS WILL OCCUR WHICH WILL LEAD TO SUCCESSIVE PRIMING PROBLEMS IS REMOTE. WHEN DIFFICULTIES WITH PRIMING HAVE OCCURRED, USE OF GAMBRO'S HELPLINE HAS RESULTED IN SUCCESSFUL COMPLETION OF THE PRIMING, SUGGESTING THAT THE ISSUE MAY BE ATTRIBUTABLE TO THE ADEQUACY OF TRAINING AS OPPOSED TO A MALFUNCTION IN THE DEVICE. WE ARE ORGANIZING A SPECIFIC TRAINING SESSION ABOUT PRIMING IN THE CONCERNED HOSPITAL. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THE REPORT AS AN ADMISSION OF LIABILITY, OR AN ACKNOWLEDGMENT THAT ITS DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. THIS EVENT IS BEING REPORTED AS PER GAMBRO POLICY; ALL CASES OF PT'S DEATH WITHIN 24 HRS. AFTER END OF THE TREATMENT ARE CONSIDERED REPORTABLE REGARDLESS OF ANY INVOLVEMENT OF A GAMBRO DEVICE.

    Description of Event or Problem · 1

    A MALE WITH ACUTE MYELOID LEUKEMIA WAS ADMITTED TO HOSPITAL FOR CHEMOTHERAPY IN 2007, HE HAD SUBCLAVIAN VEIN THROMBOSIS AND LOW PLATELETS AND DEVELOPED A CHEST INFECTION. SIX MONTHS EARLIER, HE WAS ADMITTED TO INTENSIVE CARE DUE TO A NEUTROPENIC SEPSIS FROM A STAPHYLOCOCCUS AUREUS. AT THIS POINT, HE WAS ON MENOPERAN AND AMIBIZONA IN TERMS OF DRUGS. AT 16:00, HIS CONDITION DECLINED AND HE WAS INTUBATED, VENTILATED AND NORADRENALIN WAS STARTED, HE HAD CAPILLARY LEAK SYNDROME, METABOLIC ACIDOSIS AND WAS HAVING HIS CARDIAC OUTPUT MONITORED. AT 20:00, THERE WERE DISCUSSIONS WITH THE RELATIVES ON THE SERIOUS CONDITION OF THE PT. THE NEXT DAY, THE PT CONTINUED TO DETERIORATE AND THE RELATIVES WERE APPROACHED TO INFORM THEN THAT THERE IT COULD BE WORTH TRYING HAEMOFILTRATION, ALTHOUGH, THE PT WAS STILL LIKELY TO DIE. THE RELATIVES AGREED THAT IT WOULD BE WORTH ATTEMPTING. FROM THE HOSPITAL RECORD: AS A BACKGROUND NEARBY HOSPITAL HAD REPORTED THAT THEY HAD A PROBLEM WITH SOME PRISMA SETS THAT HAD BEEN SENT TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA PRISMA M100 PRE FII GAMBRO INDUSTRIES M100 07C3097G

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death