BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1823503 · Received September 2, 2010

    Report

    Report Number
    1423500-2010-03102
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    July 11, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD873919 AND GD873901 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) REGARDING PERITONITIS IN A (B)(6) HOMECHOICE PERITONEAL DIALYSIS (PD) FEMALE PATIENT. DURING A CALL WITH BAXTER (B)(4), THE REPORTING NURSE STATED THAT ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH WAS (B)(6). TREATMENT INFORMATION WAS NOT PROVIDED FOR THE EVENT. ON AN UNREPORTED DATE IN 2010, PD THERAPY WAS WITHDRAWN AND THE PATIENT WAS PLACED ON HEMODIALYSIS. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2010, THE PATIENT RECOVERED FROM THE PERITONITIS. THE NURSE WAS UNAWARE OF THE CAUSE OF THE PERITONITIS AND STATED "THIS PARTICULAR ORGANISM WAS CAUSED BY WATER." MEDICAL HISTORY INCLUDED END STAGE RENAL DISEASE (ESRD) AND "SOME TYPE OF CYSTIC DISEASE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD WITHDRAWAL SYMPTOMS DURING THE NORMAL REFILL CYCLE. WHOLE BODY, SEVERE SPASTICITY RETURNED. THE PT HAD JUST RETURNED HOME FROM A FIVE DAY STAY AT HOSPITAL (PT ENTERED HOSPITAL ON (B)(6) 2010). CALLER INDICATED THIS WAS THE SECOND TIME THIS HAS OCCURRED TO PT WITHIN THE LAST TWO MONTHS. PT'S LAST HOSPITAL STAY WAS (B)(6) 2010 (ALSO FOR 5 DAYS). WITH BOTH OCCURRENCES, PT STARTED SHOWING SIGNS OF INCREASED SPASTICITY 4-5 DAYS PRIOR TO BEING ADMITTED TO HOSPITAL. REGARDING THE (B)(6) VISIT, PT'S DOSAGE WAS INCREASED TO 210 MCG/DAY A FEW DAYS BEFORE HOSPITALIZATION. THERE WERE NO CHANGES IN DOSAGE PRIOR TO (B)(6) 2010 HOSPITALIZATION. PT WAS GIVEN ORAL BACLOFEN TO HELP COMBAT THE WITHDRAWAL EFFECTS. PT WAS CURRENTLY BEING WEANED OFF THE ORAL AND WAS MAINTAINING WELL WITH WEANING. AFTER THE (B)(6) HOSPITALIZATION A DYE STUDY WAS PERFORMED AND NO PROBLEM WAS FOUND. IMAGING WAS PERFORMED AFTER THE (B)(6) EVENT AND NO PROBLEM WAS FOUND. AFTER THE (B)(6) HOSPITALIZATION THEY CHECKED THE PUMP FOR THE AMOUNT OF MEDICATION AND COMPARED WHAT THE EXPECTED AMOUNT SHOULD BE AND IT MATCHED UP. NO DIAGNOSTIC TESTING WAS PERFORMED ON THE PT FOR THE (B)(6) HOSPITALIZATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R DIANEAL PD4 AMBU-FLEX