MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

Report

Report Number: 1423500-2010-02554
Event Type: Injury
Date Received: August 16, 2010
Date of Event: January 1, 2010
Report Date: July 23, 2010
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H10B01028) IDENTIFYING NO ISSUES. 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.

Additional Manufacturer Narrative · 1

(B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED.

Description of Event or Problem · 1

THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF INTESTINAL INFECTION AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR E. COLI IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN INTESTINAL INFECTION. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR E. COLI. THE CAUSE OF THE PERITONITIS WAS AN INTESTINAL INFECTION. THE PATIENT DID TRANSFER TO HEMODIALYSIS. IT IS UNKNOWN IF THE PD THERAPY WAS ONGOING. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. THE REPORTER BELIEVED THAT THE BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR E. COLI WAS NOT RELATED TO PD THERAPY. NO STATEMENT OF CAUSALITY WAS GIVEN FOR THE INTESTINAL INFECTION.

Description of Event or Problem · 1

DURING A CALL FOR AN UNRELATED LOW DRAIN VOLUME ALARM, THE HOME PATIENT INDICATED HIS EFFLUENT WAS CLOUDY AND WAS BLOOD-TINGED. THE FOLLOWING INFORMATION WAS OBTAINED FROM GLOBAL PHARMACOVIGILANCE ON (B)(6) 2010: THE PATIENT'S NURSE INDICATED THE PATIENT STARTED PERITONEAL DIALYSIS (PD) THERAPY A COUPLE OF YEARS AGO (EXACT DATE UNKNOWN) WITH DIANEAL PD4 AMBUFLEX (DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEAL (IP) FOR PD. ON AN UNKNOWN DATE IN 2010, THE PATIENT EXPERIENCED CLOUDY AND BLOOD TINGED EFFLUENT AND WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE IN 2010, AN EFFLUENT ANALYSIS AND CULTURE WERE PERFORMED. THE ANALYSIS REVEALED AN ELEVATED LEUCOCYTE COUNT AND THE CULTURE REVEALED STAPHYLOCOCCUS. ON AN UNREPORTED DATE IN 2010, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS, IP. THE PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. ON UNREPORTED DATES IN 2010, THE PATIENT COMPLETED ANTIBIOTIC THERAPY AND THE PERITONITIS AND BLOOD TINGED EFFLUENT RESOLVED. DIANEAL THERAPY WAS ONGOING, DOSE UNCHANGED. MEDICAL HISTORY INCLUDED END STAGE RENAL DISEASE (ESRD). THE PATIENT WAS TAKING UNSPECIFIED CONCOMITANT MEDICATIONS. IT WAS UNKNOWN TO THE NURSE IF THE PERITONITIS AND BLOOD TINGED EFFLUENT WERE RELATED TO DIANEAL THERAPY. NO FURTHER INFORMATION IS AVAILABLE. THE FOLLOWING LOT NUMBERS WERE DELIVERED TO THE HOME PATIENT IN 2010 SO FAR (AS THE DATE OF DIAGNOSIS IS UNKNOWN): HOMECHOICE CASSETTE (PRODUCT CODE 5C4531C) 1/09: LOT H09K12012, 02/08: LOT H09L06509, 03/08: LOT H10A26092, 04/05: LOT H10B11027, 05/03, LOT H10C27013, 06/01: LOT H10D27037, 06/28: H10E21045. MINICAP DISCONNECT CAP (PRODUCT CODE 5C4466P) 02/08: LOT GD870949, 06/28: LOT GD873919. TRANSFER SET- DELIVERED TO THE PATIENT'S CLINIC (PRODUCT CODE 5C4482) 06/17/2010: H10B01028.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention	DIANEAL PD4 AMBUFLEX