BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2990412 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05321
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A CONNECTION ISSUE WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS UNAVAILABLE, THEREFORE NO EVALUATION COULD BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A MINICAP FALLING OFF OF HIS TRANSFER SET. THE HOME PATIENT (HP) NOTICED THAT HE DID NOT HAVE A MINICAP ON HIS TRANSFER SET WHEN HE WENT TO CONNECT TO THE HOMECHOICE (HC) TO DO THERAPY. THE HP COULD NOT FIND THE MINI CAP. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE HP TO CALL HIS PERITONEAL DIALYSIS REGISTERED NURSE PRIOR TO CONNECTING TO THE HC FOR FURTHER INSTRUCTIONS. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE HP. HE STATED THAT HE DEFINITELY PUT A MINICAP ON, SO THE CAP MUST HAVE FALLEN OFF OF HIS TRANSFER SET. HE DID NOT KNOW WHEN THE MINICAP HAD DISCONNECTED, NOR HOW LONG IT HAD BEEN ABSENT. HE DID NOT REPORT ANY DIFFICULTY PLACING THE MINICAP, AND DID NOT NOTE ANY DAMAGE THAT MAY HAVE CAUSED THE MINICAP TO DISCONNECT. HE CONTACTED HIS NURSE THE FOLLOWING DAY, AND SHE REPLACED HIS TRANSFER SET AND ADMINISTERED PREVENTATIVE ANTIBIOTICS. THERAPY HAS BEEN GOING WELL SINCE, AND NO ADVERSE EFFECTS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93662 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893461

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE