BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1891234 · Received November 4, 2010

    Report

    Report Number
    1423500-2010-05254
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBER; GD874859, GD877266 AND GD875567 WITH NO DEFECTS NOTED. THE AS DETERMINED CAUSE WAS POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED HEALTHCARE PROFESSIONAL FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH CEFAZOLIN 1 GRAM IP ONCE DAILY (CONTINUING) AND CEFTAZIDIME 1 GRAM IP ONCE DAILY (CONTINUING). THE EVENT OF PERITONITIS WAS RESOLVING. DIANEAL THERAPY WAS ONGOING. THE NURSE STATED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL. THE ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PATIENT WHO MADE A MISTAKE/TOUCH CONTAMINATION (CODED TO PERITONEAL DIALYSIS COMPLICATION) AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM, GRAM NEGATIVE ORGANISM, AND STAPHYLOCOCCUS EPIDERMIDIS IN PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. ON (B)(6) 2010, THE PATIENT BECAME SICK AGAIN WHICH DID NOT INVOLVE HOSPITALIZATION. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. THE NURSE DID NOT PROVIDE INFORMATION REGARDING TREATMENT. DIANEAL THERAPIES WERE ONGOING AT THE TIME OF THE EVENTS. THE PATIENT WAS RECOVERING FROM THE EVENTS. IT WAS NOT REPORTED WHETHER THE EVENT OF PATIENT TOUCH CONTAMINATION RESOLVED. PER THE NURSE, THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM, GRAM NEGATIVE ORGANISM, AND STAPHYLOCOCCUS EPIDERMIDIS WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION WITH REGARDS TO DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES.

    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 67 YR Hospitalization