BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2420820 · Received January 18, 2012

    Report

    Report Number
    1423500-2012-01380
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON 17 JAN 2012, ADDITIONAL INFORMATION WAS RECEIVED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT HAD A PD CATHETER PLACED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT'S CATHETER BECAME SLUGGISH AND "SLOW DRAINING." ON AN UNREPORTED DATE IN 2011, THE PATIENT STARTED MANUAL FLUSHES WITH UNSPECIFIED HEPARIN AND UNSPECIFIED SALINE DURING HER MENSES TO TREAT THE SLUGGISH AND "SLOW DRAINING" PD CATHETER. ON AN UNKNOWN DATE IN 2011, THE PATIENT BEGAN FLUSHING THE PD CATHETER WITH UNSPECIFIED HEPARIN DAILY AND WITH MANUAL EXCHANGES. ON (B)(6) 2011, THE NURSE MANUALLY FLUSHED THE PD CATHETER WITH TISSUE PLASMINOGEN ACTIVATOR (TPA) AND UNSPECIFIED HEPARIN. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, A SAMPLE OF THE PD EFFLUENT WAS COLLECTED AND PERITONEAL EFFLUENT CULTURE, WHITE BLOOD CELL (WBC) COUNT, RED BLOOD CELL (RBC) COUNT, NEUTROPHIL COUNT, LYMPHOCYTE COUNT, AND MONOCYTE COUNT WERE PERFORMED. THE PERITONEAL EFFLUENT CULTURE SHOWED NO GROWTH. THE PERITONEAL EFFLUENT WBC COUNT WAS ELEVATED AND THE VALUE WAS 4600 CELLS. THE RBC COUNT WAS 3CELLS, NEUTROPHIL COUNT WAS 89CELLS, MONOCYTE COUNT AND LYMPHOCYTE COUNT WERE 0CELLS. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH ANCEF AND FORTAZ FOR PERITONITIS. ON (B)(6) 2011, A BLOOD CULTURE WAS PERFORMED WHICH WAS POSITIVE FOR COAGULASE NEGATIVE STAPHYLOCOCCUS. ON (B)(6) 2011, THE PD CATHETER WAS REMOVED AND THE PD CATHETER WAS FOUND TO BE CLOTTED. ON (B)(6) 2011, ANCEF AND FORTAZ WERE DISCONTINUED AND THE PATIENT STARTED ON VANCOMYCIN. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY, TPA, HEPARIN, AND SALINE. THE CAUSE FOR THE PD CATHETER BEING SLUGGISH AND "SLOW DRAINING" WAS THE CLOT IN THE PD CATHETER. THE CLOT IN THE PD CATHETER WAS POSSIBLY DUE TO NOT USING ENOUGH HEPARIN TO FLUSH THE PD CATHETER DURING THE PATIENT'S HEAVY MENSES. BAXTER CONSIDERED TPA, HEPARIN AND SALINE AS CO-SUSPECT. THE PATIENT HAD A PAST MEDICAL HISTORY OF A HEAVY MENSES.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD889485, GD889477 AND GD888115 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 1 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE IN THE USA OF PROBLEMS WITH THE PATIENT'S CATHETER AND FLOW AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THERE WERE PROBLEMS WITH THE PATIENT'S CATHETER AND FLOW. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. TREATMENT WAS NOT REPORTED. THE PATIENT HAD RECOVERED FROM PERITONITIS. THE OUTCOME OF THE PROBLEMS WITH THE PATIENT'S CATHETER AND FLOW WAS NOT REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2011, DIANEAL THERAPY WAS WITHDRAWN. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY AND DID NOT COMMENT ON THE PROBLEMS WITH THE PATIENT'S CATHETER AND FLOW. PER THE NURSE, THE PROBLEMS RELATED TO THE PATIENT'S CATHETER AND FLOW MIGHT HAVE CAUSED THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other DIANEAL PD4 ULTRABAG| HOMECHOICE