BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1960677 · Received January 13, 2011

    Report

    Report Number
    1423500-2011-00589
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    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). THE SAMPLE WAS RECEIVED FOR EVALUATION. THIS COMPLAINT WAS CONFIRMED BY EVALUATION AS A CRACKED MINICAP, BUT DID NOT CONFIRM A LEAK DURING FUNCTIONAL TESTING. THERE IS SUBSTANTIAL FUNCTIONAL TESTING PERFORMED DURING MANUFACTURE TO MONITOR PRODUCT SUSCEPTIBILITY INCLUDING TIGHTENING ON A CONNECTOR AND LEAK TESTING. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. NO FUNCTIONAL TEST FAILURES WERE FOUND DURING IN-PROCESS QA TESTING DURING PRODUCTION OF THIS BATCH WHICH WOULD ACCOUNT FOR THE OCCURRENCE OF THIS TYPE OF PROBLEM. A ROOT CAUSE OF CRACK WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). NUMBER 3 OUT OF 4 EMDRS. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 4 ASSOCIATED WITH THIS PRODUCT. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER RECEIVING CRACKED MINICAPS. THE HOME PATIENT (HP) COULD NOT USE THEM. DURING A FOLLOW-UP WITH THE HP, IT WAS FOUND THAT THE TRANSFER SET WAS IN USE FOR 6 MONTHS. THE PATIENT VERIFIED THAT HE USED PROPER CONNECTION TECHNIQUE BY TWISTING THE MINICAP CLOCKWISE ONTO THE TRANSFER SET CONNECTOR UNTIL FIRMLY SECURED. DURING FURTHER FOLLOW UP WITH THE HP TO OBTAIN CLARIFICATION ON THE NUMBER OF SAMPLES SENT FOR EVALUATION, IT WAS REVEALED THAT HE SENT 4 USED MINICAPS, WHICH HAD CRACKS IN THEM, BUT NO LEAKS WERE NOTED. THE CRACKS WERE NOTED AFTER HE HAD PLACED THE MINICAP ON THE TRANSFER SET. PER HP, THE MINICAPS WERE ATTEMPTED TO BE USED ON THE SAME TRANSFER SET. THE HP IS DOING FINE AND CONTINUING THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING A FOLLOW UP WITH THE HOME PATIENT (HP)'S NURSE TO FIND OUT THE TRANSFER SET BRAND NAME (PER REQUEST FROM BAXTER'S QUALITY ENGINEERS), THE NURSE STATED THAT THEY ONLY USE BAXTER'S TRANSFER SETS. THE NURSE THEN VOLUNTARILY ADDED THAT SHE HAS ABOUT 30 OTHER PERITONEAL DIALYSIS (PD) PATIENTS, AND NO ONE EVER REPORTED SUCH A PROBLEM. THE NURSE FEELS IT IS LESS LIKELY THAT THE ALLEGED CRACKS WERE A PRODUCT DEFECT .THE NURSE STATED THAT THE HP ONLY REPORTED THIS ISSUE TO HER AFTER HAVING SENT THE SAMPLES BACK TO BAXTER. THE NURSE WANTED TO KNOW THE RESULTS OF INVESTIGATION. THE NURSE CONFIRMED THAT HP DID NOT HAVE ANY INJURY NOR NEEDED ANY MEDICAL INTERVENTION. PER NURSE, HP IS DOING FINE AND CONTINUING THERAPY. ON (B)(4) 2011, THE QUALITY MANAGER AND THE ASSOCIATE EVALUATING THE DAMAGED MINICAP COMPLAINTS CONTACTED THE HP TO OBTAIN ADDITIONAL INFORMATION. THE HP STATED THAT HE HAD OBSERVED THE CRACKS IMMEDIATELY AFTER ATTACHING. THE HP STATED THAT HE DID NOT ATTACH THE CAPS TOO TIGHTLY. THE CAPS REPORTEDLY JUST SEEMED TO BREAK. THE HP ALSO STATED THAT HE ALSO RUNS HIS FINGER AROUND THE BODY OF THE MINICAP TO SEE IF HE COULD "FEEL" A CRACK BEFORE PUTTING THEM ON. ACCORDING TO THE HP, THE MINICAPS DID NOT APPEAR TO BE CRACKED IN THE POUCH, AND HE HAD NOT SEEN ANYTHING IRREGULAR INSIDE THE POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD878843

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR TRANSFER SET