AUTOMATED PD SET W/CASSETTE4 PRONG

Report

Report Number: 1423500-2010-06330
Event Type: Injury
Date Received: November 29, 2010
Date of Event: October 1, 2010
Report Date: October 5, 2010
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. 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). THE SAMPLE WAS DISCARDED AND LOT NUMBERS ARE UNKNOWN, THEREFORE NO EVALUATION WAS PERFORMED. ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem · 1

IT WAS REPORTED IN AN ABSTRACT TITLED "COMPARISON OF CLINICAL EFFECT BETWEEN PVP AND PKP FOR TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", THAT: 30 PATIENTS UNDERWENT OPERATIONS WITH PVP (PERCUTANEOUS VERTEBROPLASTY) AND 45 UNDERWENT OPERATIONS WITH PKP (PERCUTANEOUS KYPHOPLASTY). THE OPERATIONS WERE SUCCESSFUL IN ALL PATIENTS. IN 16 CASES OF PVP AND 11 CASES OF PKP, CEMENT LEAKAGE OCCURRED; HOWEVER, WITHOUT CLINICAL SYMPTOMS. NO FURTHER INFORMATION WAS REPORTED. IT IS UNKNOWN IF THE BONE CEMENT USED WAS HV-R. NOTE: MEDTRONIC SPINE, LLC DOES NOT CURRENTLY DISTRIBUTE PRODUCT IN CHINA

Description of Event or Problem · 1

INITIALLY, THE PATIENT CALLED FOR ASSISTANCE RELATED TO A CHECK PATIENT LINES AND BAGS ALARM. DURING THE CALL THE PATIENT INDICATED SHE WAS ON ANTIBIOTICS. DURING A FOLLOW UP CALL ON (B)(6) 2010, THE NURSE STATED THAT THE PATIENT HAD THE HOMECHOICE UNIT SWAPPED OUT. THE NURSE CONFIRMED THE PATIENT WAS BEING TREATED WITH UNKNOWN ANTIBIOTICS FOR PERITONITIS. ON (B)(6) 2010, ADDITIONAL INFORMATION WAS RECEIVED FROM THE RN CARING FOR THE PATIENT WHILE HOSPITALIZED. THIS (B)(6) PATIENT WAS HOSPITALIZED THE FIRST TIME FOR PERITONITIS ON (B)(6) 2010. THE PATIENT HAD BEEN ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) (UNKNOWN SOLUTION AND MANUFACTURER) AT HOME FOR 12 YEARS PRIOR TO THIS DATE, AND NEVER HAD AN INFECTION. THE EFFLUENT CULTURED POSITIVE FOR (B)(6), CELL COUNT UNKNOWN. SHE ALSO WAS POSITIVE FOR CDIFFICELE AND (B)(6) OF UNKNOWN ORIGIN. AMBULATORY PERITONEAL DIALYSIS (APD) WAS INITIATED WITH THE HOMECHOICE (HC), BUT THE PERITONEAL DIALYSIS (PD) EFFLUENT WAS SO THICK AND YELLOW, THAT THE PATIENT HAD DIFFICULTY DRAINING. THE NURSE CALLED BAXTER THAT NIGHT FOR ASSISTANCE, AND AFTER MUCH TROUBLESHOOTING, HAD THE HC SWAPPED. THE CATHETER WAS LATER IRRIGATED BY THE RESIDENTS WITH HEPARIN, AND THE SOLUTION HEPARINIZED. THE PATIENT THEN DRAINED WITHOUT DIFFICULTY. INTRAVENOUS (IV) TREATMENT WAS INITIATED AFTER CULTURES WERE OBTAINED, CONSISTING OF VANCOMYCIN, ZOSYN AND CIPROFLOXIN (DOSES UNKNOWN). INTRAPERITONEAL (IP) GENTAMYCIN WAS ALSO INITIATED. AFTER DISCHARGE, THE PATIENT WAS READMITTED FOR THE ONGOING PERITONITIS ON (B)(6) 2010. THE PD CATHETER WAS BELIEVED TO BE THE CAUSE WITH A POSSIBLE TUNNEL INFECTION PRESENT. THE CATHETER WAS REMOVED, AND THE PATIENT STARTED HEMODIALYSIS. TREATMENT DURING THE SECOND ADMISSION IS UNKNOWN AS IS ANY CULTURE RESULTS. THE DISCHARGE DATE AND THE PATIENT OUTCOME IS ALSO UNKNOWN. THE NURSE WAS NOT SURE FROM WHICH PD CLINIC THE PATIENT IS TREATED, ONLY THAT SHE THOUGHT IT WAS IN (B)(6). THE RN DID NOT HAVE AN OPINION ON THE ORIGIN OF THE INFECTION OR CAUSALITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOMATED PD SET W/CASSETTE4 PRONG	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Hospitalization\| R