MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN
Report
- Report Number
- 1423500-2010-06366
- Event Type
- Injury
- Date Received
- November 30, 2010
- Date of Event
- November 17, 2010
- Report Date
- November 17, 2010
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
(B)(4). THE SAMPLE INVOLVED HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. A 510(K) NUMBER WILL NOT BE PROVIDED AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.
(B)(4).
(B)(4). THE ROOT CAUSE IS UNDETERMINED. THE REPORTED CONDITION WAS CONFIRMED IN THE LAB. THE PATIENT CONNECTOR LUER LOOSENED IN THE TUBING/BUSHING AND CAME OUT. THE TUBING IS HELD ON THE PATIENT CONNECTOR LUER BY FRICTION FIT. THERE WAS NO INDICATION THAT THE LUER CONNECTOR OR TUBING IN THIS CASE WAS DAMAGED OR ABNORMAL. THE ROOT CAUSE WAS NOT DETERMINED DURING THE PLANT EVALUATION. A BATCH REVIEW WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. INSERTION INTEGRITY IS 100% CHECKED AFTER ASSEMBLY. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.
(B)(4).
THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF CLOUDY PERITONEAL EFFLUENT IN A FEMALE PATIENT COINCIDENT WITH DIANEAL N AND EXTRANEAL THERAPY. IN 2009, THE PATIENT BEGAN HER PERITONEAL DIALYSIS (PD) THERAPY WITH A COMPETITOR PD SYSTEM. IN (B)(6) 2010, SHE CHANGED HER PD SYSTEM TO THE BAXTER HOMECHOICE PRO SYSTEM. THE PATIENT ALSO USED DIANEAL N PD-2 2.5% SYSTEM II 5000ML X 2BAGS AND EXTRANEAL SYSTEM II 2000ML X 1BAG/DAY. ON (B)(6) 2010, THE PATIENT FELT HER CLOTHES WET AND NOTICED THAT THE PATIENT CONNECTOR WAS SEPARATED FROM THE TUBING IN REGARD TO HER CONTINUOUS AMBULATORY PD MINICAP TRANSFER SET(24CM). THE PATIENT RECONNECTED THE TUBING TO THE PATIENT CONNECTOR BY HAND. THE PATIENT'S TRANSFER SET HAD BEEN IN USE FOR ABOUT 30 DAYS. ON THE SAME DATE, THE PATIENT WENT TO THE HOSPITAL AND HER PERITONEAL EFFLUENT WAS CLOUDY AND THE LEUKOCYTE COUNT IN HER PERITONEAL EFFLUENT WAS 900/MM3. ABDOMINAL PAIN WAS NOT OBSERVED. THE PATIENT'S TRANSFER SET WAS EXCHANGED AND ANTIBIOTICS WERE GIVEN. AS OF (B)(6) 2010, THE PATIENT WAS NOT RECOVERED FROM THE EVENT. THE NURSE INDICATED THAT A PHYSICIAN ASSESSED THE EVENT AS SERIOUS. THE PHYSICIAN THOUGHT THAT THE EVENT WAS NOT RELATED TO DIANEAL N OR EXTRANEAL. ADDITIONAL INFORMATION RECEIVED FROM A PHYSICIAN ON 19NOV2010 IS AS FOLLOWS: THE PHYSICIAN DIAGNOSED THE EVENT AS PERITONITIS. THE PHYSICIAN THOUGHT THAT THE CAUSALITY BETWEEN THE EVENT AND THE CAPD MINICAP TRANSFER SET WAS DEFINITELY RELATED. THIS DEFECT WAS A SEPARATION OF THE TRANSFER SET ITSELF, AND NO OTHER PRODUCT WAS RELATED. NO FURTHER INFORMATION IS AVAILABLE. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION.
THE PATIENT CONNECTOR WAS REMOVED FROM THE TUBING BY THE HOSPITAL STAFF AFTER THE PATIENT REPLACED IT.
THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT'S PHYSICIAN ON (B)(6) 2010: ON AN UNREPORTED DATE, THE PATIENT WAS RECOVERED FROM THE EVENT AND DISCHARGED FROM THE HOSPITAL. AS OF (B)(6) 2010, THE PATIENT'S PERITONEAL DIALYSIS THERAPY WAS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | DIANEAL N PD-2 2.5% AND EXTRANEAL |