BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1896967 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05634
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO POOR ASEPTIC TECHNIQUE. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H09L29014 AND H10G19102) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. A LABELING REVIEW FOUND THE HOMECHOICE USER'S MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. 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. THIS MEDICAL DEVICE REPORT IS AGAINST THE CASSETTE. TWO PRODUCT CODES WERE SHIPPED TO THE PATIENT WITHIN (B)(6) OF THE INCIDENT AND IT WAS UNKNOWN WHICH PRODUCT CODE WAS BEING USED AT THE TIME OF THE INCIDENT. THEREFORE, THE PRODUCT CODE IS UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(4) OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND FUNGAL PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER (B)(4), THE NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE IN 2010, PD THERAPY WAS WITHDRAWN. THE PATIENT WAS RECOVERING FROM PERITONITIS. THE OUTCOME OF MADE A MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT DURING THE RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, DURING ADVANCEMENT THE RECOVERY CATHETER WAS CATCHING ON THE STRUT OF THE DEPLOYED ACCULINK STENT. THE RECOVERY CATHETER COULD NOT PASS THROUGH THE STENT BECAUSE OF THE STENT STRUT ANGLE AND THE WIRE BIAS AGAINST IT, DESPITE NECK MASSAGE AND MANIPULATION. THE RECOVERY CATHETER WAS REMOVED AND ANOTHER RECOVERY CATHETER WAS USED TO REMOVE THE FILTER. THERE WAS NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R DIANEAL PD4 AMBUFLEX