BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2200213 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10525
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR H11C31030 AND AN EXCEPTION WAS NOTED FOR MOLDING DEFECT ASSOCIATED WITH THE CONNECTOR COMPONENT. THERE IS NO EVIDENCE TO SUPPORT ASSOCIATION TO THE REPORTED PROBLEM. THE AFFECTED PRODUCT WAS 100% INSPECTED. CORRECTIVE ACTIONS IMPLEMENTED AND EFFECTIVE. QUALITY INSPECTIONS WERE ACCEPTABLE WITH ALL PRODUCT RELEASE REQUIREMENTS ACCEPTABLE. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA (B)(4).

    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 2 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    INITIALLY, THE PATIENT CALLED THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A CHECK SUPPLY LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC), DURING PRIME. THE TSR ASSISTED THE HP TO COMPLETE THE PRIME. THE SOLUTION WAS PROVIDED OVER THE PHONE AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL CALL. ON (B)(4) 2011, DURING A FOLLOW UP CALL WITH THE PATIENT BY BAXTER PRODUCT SURVEILLANCE REGARDING THE CHECK SUPPLY LINE ALARM, THE PATIENT STATED THE SAMPLE HAD BEEN DISCARDED AND THERE WAS NO LOT NUMBER AVAILABLE. DURING THE CONVERSATION, THE HP SAID THE NEXT DAY AFTER THE INCIDENT WITH THE ALARM, HE WENT TO HIS CLINIC AND HE WAS DIAGNOSED WITH PERITONITIS. THE HP SAID HE WAS GIVEN ANTIBIOTICS AND THAT HE IS FEELING BETTER. NO FURTHER INFORMATION WAS PROVIDED BY THE CONSUMER ON THE INITIAL FOLLOW UP CALL. ON 08AUG2011, PRODUCT SURVEILLANCE FOLLOWED UP WITH THE PATIENT'S PERITONEAL DIALYSIS NURSE (PDN) WHO PROVIDED THE FOLLOWING INFORMATION. THE PDN CONFIRMED THAT THE PATIENT WAS DIAGNOSED WITH PERITONITIS COINCIDENT WITH 2.5 % DIANEAL AMBUFLEX AND ICODEXTRIN THERAPY (DOSES, FREQUENCIES AND LOTS WERE NOT REPORTED). THE PATIENT WAS NOT HOSPITALIZED AND RECEIVED REMEDIAL TREATMENT WITH AN UNSPECIFIED ANTIBIOTIC. ON AN UNSPECIFIED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PDN STATED THE PATIENT IS USING UNSPECIFIED DISPOSABLE PRODUCTS WITH LUER CONNECTORS. THE PDN STATED THAT THE PATIENT WAS EXPERIENCING DIARRHEA AT THE TIME THAT THE PERITONITIS OCCURRED. THE PDN STATED THE CAUSE OF THE PERITONITIS WAS UNKNOWN, HOWEVER, COULD BE INTERNAL. THE PDN DID NOT CONSIDER THE PERITONITIS TO BE RELATED TO THE PD THERAPY AND NOT RELATED TO ANY BAXTER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention ICODEXTRIN| 2.5 % DIANEAL AMBUFLEX