BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1897020 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05672
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 (H10G22122 AND H10F30085 ) 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 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 2 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF A SCARRED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE. THE ACCESS PORTS WERE USED UNSUCCESSFULLY AND COUNTER TRACTION AND ASSERTIVE PULL WERE USED TO REMOVE THE DEVICE FROM THE PATIENT ANATOMY. THE CLIP OF THE DEVICE ACHIEVED HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF OTHER PROBLEMS FROM A PREEXISTING STROKE, PATIENT MADE A MISTAKE/TOUCH CONTAMINATION/DID NOT WEAR A MASK, AND PERITONITIS WITH CULTURE POSITIVE FOR STAPH EPIDERMIDIS COAGULASE NEGATIVE (NEG) STAPH IN PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER'S CUSTOMER SERVICE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE AND WAS HOSPITALIZED (DATE OF ONSET AND HOSPITALIZATION NOT REPORTED). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS PATIENT MADE A MISTAKE/ TOUCH CONTAMINATION/ DID NOT WEAR A MASK. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. TREATMENT FOR THE EVENTS WERE NOT REPORTED. PD THERAPY WAS DISCONTINUED (DATE NOT REPORTED). THE OUTCOME FOR THE EVENT OF OTHER PROBLEMS FROM A PREEXISTING STROKE AND PATIENT MADE A MISTAKE/ TOUCH CONTAMINATION/ DID NOT WEAR A MASK WAS NOT REPORTED. THE PATIENT HAD RECOVERED FROM THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR STAPH EPIDERMIDIS COAGULASE NEG STAPH AT THE TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG