BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2032898 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03809
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD881466 WITH NO DEFECTS NOTED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD879924 WHICH REVEALED VOIDS WERE NOTED IN THE POUCH SEAL DURING MANUFACTURING. CORRECTIVE ACTIONS WERE IMPLEMENTED BY THE MANUFACTURING FACILITY AND A RE-INSPECTION OF THE LOT WAS PERFORMED WHICH REVEALED ALL AFFECTED UNITS WERE REMOVED PRIOR TO RELEASE OF THE LOT. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENT DISCARDS SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP INFORMATION WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011 DURING A CALL FOR AN UNRELATED ALARM, THE PATIENT REPORTED THAT HE HAD BEEN HOSPITALIZED FOR PERITONITIS. ON (B)(6) 2011 DURING A FOLLOW UP CALL WITH THE PERITONEAL DIALYSIS (PD) NURSE, SHE REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TREATED AT THE HOSPITAL FROM (B)(6) 2011 TO (B)(6) 2011 FOR PERITONITIS. SHE ALSO REPORTED THE PATIENT WAS HOSPITALIZED AT AN UNKNOWN HOSPITAL FROM (B)(6) TO (B)(6) 2011 FOR A FALL. SHE REPORTS THAT THE PATIENT'S ACCOUNT OF DARK PD DRAINAGE ON (B)(6) 2011 WAS DUE TO A FIBRIN BLOCK. THE PATIENT CAME IN TO THE PD CLINIC ON (B)(6) 2011 AND THE FIBRIN BLOCK WAS REMOVED AND THE PD EFFLUENT WAS CLEAR. DURING THE PATIENT'S HOSPITALIZATION IN (B)(6) 2011 PD CULTURES, CELL COUNT AND GRAM STAINS WERE DONE ON AN UNKNOWN DATE. THE PD NURSE REPORTS THAT THE PATIENT WAS TREATED WITH VANCOMYCIN INTRAVENOUS (UNKNOWN DOSE) AND GENTAMICIN INTRAVENOUS (UNKNOWN DOSE) DURING HOSPITALIZATION. ON (B)(6) 2011 PD CULTURES AND CELL COUNTS WERE DONE. THIS EPISODE IS RESOLVED AND THE PATIENT CONTINUED PD THERAPY WITHOUT DIFFICULTY. THERE WAS NO EXIT SITE INFECTION. THE PD NURSE DID NOT KNOW THE CAUSE OF THE PERITONITIS AND REPORTED THAT THE PATIENT HAS VERY GOOD ASEPTIC TECHNIQUE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOME CHOICE CYCLER| DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG