MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

Report

Report Number: 1423500-2010-03612
Event Type: Injury
Date Received: September 22, 2010
Date of Event: August 1, 2010
Report Date: August 19, 2010
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H10A20038 AND H10B25035), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. 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.THIS REPORT IS RELATED TO MEDWATCH REPORT NUMBER 1423500-2010-03610.

Description of Event or Problem · 1

A HOMECHOICE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE TO END THERAPY DURING DWELL 3 OF 4. THE HP STATED SHE NEEDED TO END THERAPY TO GO TO THE HOSPITAL AND DID NOT SAY WHY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP IN ENDING THERAPY PER THE HP'S REQUEST. THE HOMECHOICE WAS OPERATIONAL. ON (B)(6)2010, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE HP'S PERITONEAL DIALYSIS (PD) NURSE: ON AN UNREPORTED DATE, THE HP STARTED THERAPY WITH LOCAL (PD4) AMBUFLEX. THE HP WAS DIAGNOSED WITH BACTERIAL PERITONITIS ON (B)(6)2010 AND WAS HOSPITALIZED FROM (B)(6)2010 TO (B)(6)2010. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THIS PERITONITIS EVENT. A CELL COUNT, CULTURE, AND GRAM STAIN WERE PERFORMED ON THE HP'S EFFLUENT ON (B)(6)2010. THE CELL COUNT SHOWED 17700 LEUCOCYTES, THE GRAM STAIN SHOWED MORE THAN 3 WHITE BLOOD CELLS, AND THE CULTURE SHOWED KLEBSIELLA PNEUMONIAE AS THE CAUSATIVE ORGANISM. THE NURSE INDICATED THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HAS RECOVERED FROM THE PERITONITIS. THE NURSE INDICATED THE CAUSE OF THE PERITONITIS WAS POOR ASEPTIC TECHNIQUE, AND WAS NOT DUE TO ANY OF THE HP'S BAXTER PD SOLUTIONS OR PD DEVICES. NO FURTHER INFORMATION IS AVAILABLE. THE FOLLOWING ARE POTENTIALLY ASSOCIATED LOTS FOR THIS PERITONITIS EVENT: HOMECHOICE CASSETTE (PRODUCT CODE 5C4531C, LOTS H10E10048 AND H10F16050), MINICAPS (PRODUCT CODE 5C4466P, LOTS GD873901, GD874834, GD874842, GD875559, AND GD875567), TRANSFER SET (PRODUCT CODE 5C4482, LOTS H10A20038 AND H10B25035).

Description of Event or Problem · 1

A CONSUMER AND A NURSE FROM THE USA REPORTED AN EVENT OF PERITONITIS IN AN (B)(6) FEMALE PATIENT. REPORTEDLY, THE PATIENT CHOSE TO STOP DIALYSIS THERAPY. ON (B)(6)2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THAT THE PATIENT EXPIRED ON (B)(6)2010, DUE TO PERITONITIS (UNSPECIFIED). THE FACILITY NURSE INDICATED THE PATIENT'S CAUSE OF DEATH WAS DISCONTINUATION OF DIALYSIS THERAPY. IT UNKNOWN IF TREATMENT FOR THE PERITONITIS WAS PROVIDED PRIOR TO THESE EVENTS. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING UNTIL THE DATE OF DEATH. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE DISCONTINUATION OF THERAPY WAS UNRELATED TO DIANEAL THERAPY. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE FATAL PERITONITIS. IT IS UNKNOWN WHAT TREATMENTS WERE PROVIDED FOR THE PERITONITIS.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Hospitalization\| R	LOCAL (PD4) AMBUFLEX