MINI-CAP, DISCONNECT W/PVP-1SOLUTION

Report

Report Number: 1423500-2010-03113
Event Type: Injury
Date Received: September 2, 2010
Date of Event: August 4, 2010
Report Date: August 4, 2010
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

Additional Manufacturer Narrative · 1

(B)(4). THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS GD874826 AND GD873893 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS IS THE SECOND OF FIVE COMPLAINTS ASSOCIATED WITH THIS EVENT.

Description of Event or Problem · 1

DURING A CALL FOR AN UNRELATED ISSUE, THE PATIENT INDICATED HE HAD PERITONITIS WHICH WAS DIAGNOSED ON (B)(6) 2010. THE PATIENT STATED THAT HE FELT ABDOMINAL PAIN ON (B)(6) 2010 AND WENT TO THE CLINIC (B)(6) 2010. THE PATIENT STATED THAT THE PERITONITIS HAS NOT STOPPED HIM FROM BEING PHYSICALLY ACTIVE OR WORKING. DURING FOLLOW-UP WITH THE PATIENT'S PERITONEAL DIALYSIS NURSE ON (B)(6) 2010, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE PATIENT BEGAN WITH AUTOMATED PERITONEAL DIALYSIS THERAPY ON (B)(6) 2009 WITH LOCAL (PD4) AMBUFLEX. THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS ON (B)(6) 2010. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS AND THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. THE PATIENT'S PERITONEAL DIALYSIS EFFLUENT WAS SAMPLED ON (B)(6) 2010 AND THE ANALYSIS SHOWED 2563 LEUCOCYTES, 91% NEUTROPHILS, AND 8% LYMPHOCYTES. THE GRAM STAIN SHOWED GRAM POSITIVE (B)(6) AND THE CULTURE SHOWED COAGULASE NEGATIVE (B)(6). THE NURSE INDICATED THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE PATIENT HAS BEEN ABLE TO CONTINUE WITH PERITONEAL DIALYSIS THERAPY AND THE PERITONITIS IS IMPROVING. THE NURSE INDICATED THE PATIENT'S TRANSFER SET WAS NOT REPLACED AFTER THE PERITONITIS WAS DIAGNOSED. THE NURSE ALSO INDICATED THE LIKELY CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. THERE WAS NO ALLEGATION MADE AGAINST ANY OF THE PATIENT'S PERITONEAL DIALYSIS DISPOSABLES OR SOLUTIONS.

Description of Event or Problem · 1

BAXTER RECEIVED A REPORT FROM A NURSE REGARDING PERITONITIS IN A (B)(6) MALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. ON (B)(6) 2010 THE NURSE REPORTED THAT THE PATIENT HAD PERITONITIS AND HIS CATHETER WAS REMOVED. THE PATIENT IS NOW ON HEMODIALYSIS. (B)(6) 2010, ADDITIONAL INFORMATION WAS OBTAINED FROM THE DIALYSIS NURSE. THE PATIENT HAD BEEN DIAGNOSED WITH (B)(6) ON (B)(6) 2010. THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT HAD THE PD CATHETER REMOVED AND WAS STARTED ON HEMODIALYSIS. THE PD EFFLUENT WAS ANALYZED ON (B)(6) 2010 AND THE WHITE BLOOD CELL COUNT WAS 4086 MM3 AND WAS DETERMINED TO BE (B)(6). IT IS UNKNOWN WHAT TREATMENT THE PATIENT RECEIVED FOR THE PERITONITIS. THE NURSE STATED THE PERITONITIS WAS DUE TO TOUCH CONTAMINATION AND THAT IT WAS NOT RELATED TO ANY BAXTER PRODUCTS OR SOLUTIONS. RETRAINING WAS NOT PERFORMED AS THE PD CATHETER WAS REMOVED AND THE PATIENT WAS STARTED ON HEMODIALYSIS. PAST MEDICAL HISTORY INCLUDES END STAGE RENAL DISEASE, HYPERTENSION, DIABETES, HEART DISEASE, CONGESTIVE HEART FAILURE, PNEUMONIA AND A FOOT ULCER.

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Required Intervention	DIANEAL LOW CAL, ULTRA BAG DEXTROSE 1.50% DIANEAL