BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2240693 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11935
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER FOLLOW UP WITH THE PATIENT, THE SAMPLE WAS NO LONGER AVAILABLE FOR EVALUATION. THIS REPORT FOR A MINICAP WITH INADEQUATE IODINE WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A MINI-CAP THAT DID NOT HAVE A SPONGE OR IODINE INSIDE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING INITIAL DRAIN. THE PATIENT WAS CONNECTED TO THE HC AT THE TIME OF THE CALL. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE PATIENT IF THE MINI-CAP PACKAGE HAD BEEN COMPLETELY SEALED. THE PATIENT STATED YES, BUT THERE WAS NO SPONGE OR IODINE IN THE CAP WHEN THEY REMOVED IT TO START DRAINING. WHILE THE TSR WAS SPEAKING WITH THE PATIENT, THE PATIENT STATED THEY HAD DROPPED THE MINI-CAP ON THE FLOOR. THE TSR ASKED THE PATIENT IF THEY PLACED THE MINI-CAP ON THE TRANSFER SET AND THE PATIENT STATED NO. THE TSR ADVISED THE PATIENT TO PRESS STOP ON THE HC AND TO CONTACT THEIR PERITONEAL DIALYSIS REGISTERED NURSE FOR FURTHER INSTRUCTIONS. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011 REGARDING THE REPORT OF A MINI-CAP WITH NO SPONGE OR IODINE. THE PATIENT STATED, WHEN THEY REMOVED THE MINI-CAP FROM THEIR TRANSFER SET AND CONNECTED TO THE HC THEY NOTICED THAT THERE WAS NO SPONGE IN THE CAP AND THERE DID NOT APPEAR TO HAVE BEEN ANY IODINE. THE PATIENT STATED THAT THE MINI-CAP APPEARED TO HAVE NOTHING IN IT. THE PATIENT HAD NOT NOTICED ANY DAMAGE TO THE PACKAGING WHEN THEY HAD REMOVED THE MINI-CAP AND PUT IT ON THE TRANSFER SET ORIGINALLY. THE PATIENT STATED, SINCE THEN THEY HAD RECEIVED A NEW BOX OF MINI-CAPS. THE PATIENT HAD SPOKEN WITH THEIR DOCTOR ABOUT THE ISSUE WITH THEIR MINI-CAP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 GD886028

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR HOMECHOICE