FRESENIUS FREEDOM CYCLER

Report

Report Number: MW1019934
Event Type: Injury
Date Received: September 14, 2000
Date of Event: August 25, 2000
Report Date: September 12, 2000
Manufacturer: FRESENIUS USA CORPORATE HEADQUARTERS
Product Code: KPF
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: WI, US
Reporter Occupation: NURSE

Narratives

Description of Event or Problem · 1

ORGANIZATION HAS EXPERIENCED AN INCREASED INFECTION RATE IN HOME PERITONEAL DIALYSIS PTS SINCE CHANGING TO FRESENIUS PRODUCTS. THIS HAS RESULTED IN TEN TOTAL EPISODES OF PERITONITIS IN FOUR PTS, OUT OF A TOTAL OF NINE PTS. FOUR EPISODES HAVE RESULTED IN HOSPITALIZATIONS. RPTR HAS A GRAPH, WHICH ILLUSTRATES THE PROBLEM. DATA COLLECTION TOOL PROVIDES MULIPTLE ASPECTS OF EVALUATION INCLUDING DATE OF ONSET, TIME PERIOD BETWEEN PRODUCT INTRODUCTION, CULTURE DATE AND PATHOGENS ISOLATED. PLEASE NOTE THE RECURRENCE OF ACINETOBACTER LWOFFI IN THREE OF THE PT'S CULTURES AS WELL AS OTHER UNUSUAL GRAM NEGATIVE RODS ORGANISMS. SUSPECTED MEDICAL DEVICE AND PRODUCT: FRESENIUS FREEDOM CYCLER AND PRODUCTS. HOSP STARTED THE CHANGE OVER AT THE END OF THE MONTH, WHICH CONTINUED FOR 3 MONTHS. SINCE THE NOTIFICATION OF THESE EVENTS TO INFECTION CONTROL RECOMMENDATION WAS ACCEPTED TO DISCONTINUE THE USE OF THIS SYSTEM. SINCE THE PRODUCTS ARE SHIPPED TO THE HOME BY FRESENIUS, RPTR DOES NOT HAVE THE LOT NUMBERS OF THE PD BAGS OR TUBING. THE CO HAS NOT YET PROVIDED THE SPECIFIC LOT NUMBERS (REQUESTED). RPTR HAS RECEIVED A GENERALIZED LOT NUMBER AND STERILITY OF PRODUCTS. SINCE THE TUBING MFG AND TESTING IS NOT COMPLETED BY FRESENIUS, RPTR IS STILL AWAITING THIS DOCUMENTATION. HOSP HAS COMPLETED ENVIRONMENTAL CULTURES OF THE PRODUCT IN ORGANIZATION AND HAS NOT ISOLATED ANY ORGANISMS. HOSP IS AWAITING A SHIPMENT OF THE BAXTER SYSTEM AND WILL BE CHANGING OUT THE PRODUCTS IN THE HOME. IN THE MEANTIME, THE NURSING STAFF HAS SPOKEN TO THE PTS TO REINFORCE PROCEDURE INCLUDING HAND WASHING AND THEY HAVE EVALUATED FOR ANY EXPIRED PRODUCTS. THE EXPIRATION DATES ON THE TUBING ARE CONFUSING, BEING LOCATED IN DIFFERENT PLACES DEPENDING ON THE NUMBER OF LEADS. SOME CONTAIN A LABEL ON THE FRONT OF THE FACE SHEET INSIDE THE CLEAR PACKAGE WHICH STATES THE EXPIRATION DATE AND "OR 45 DAYS AFTER OPENING FOIL BAG, WHICHEVER IS FIRST" AND OTHERS HAVE IT PRINTED ON THE RIGHT EDGE OF THE PACKAGE AND THE SAME WORDING IN THE LOWER LEFT CORNER. INFECTION CONTROL HAS BEEN EDUCATED ON THE SYSTEM WHICH ACTIVATES THE PROCESS OF DIALYSIS. THE PRODUCT REQUIRES THE USER TO CLAMP IN THREE PLACES AFTER THE PROCESS IS COMPLETED AND BREAK THE TUBING LEAVING ABOUT FOUR INCHES OF DEAD SPACE, STILL FILLED WITH FLUID, CONNECTED TO THE PT UNTIL THE NEXT DIALYSIS (USUALLY EVERY EVENING). IF THE TWO CLAMPS ABOVE THIS ARE NOT CORRECTLY COMPLETED, MIGRATION OF ORGANISMS COULD OCCUR. EACH TUBING CONTAINS MALE AND FEMALE PORT(S) LOADED WITH BETADINE. RPTR HAS THE DEVICE AND PRODUCTS AVAILABLE FOR EVALUATION. AFTER THE EXCHANGE OF SYSTEMS, RPTR WILL HOUSE THE PT'S PRODUCTS WITHIN INSTITUTION UNTIL THE INVESTIGATION IS COMPLETED. ACCORDING TO MFR MORE THAN 1200 SAMPLES FROM LOTS IDENTIFIED WITH THE REFERENCED COMPLAINT HAVE SUCCESSFULLY PASSED USP STERILITY TESTING INFERRING THAT EACH LOT OF PRODUCT IS STERILE AS LABELED. DELFLEX PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE LOW MG, LOW CA. QUALITY ASSURANCE REQUIRED THE TESTING OF THREE SAMPLES (FIRST, MIDDLE AND LAST) FROM EACH LOT FOR THE PRESENCE OF BACTERIAL ENDOTOXIN (PYROGEN). THE RESULTS FROM DUPICATE TESTING OF EACH SAMPLE BY THE KINETIC TURBIDOMETRIC LAL METHOD SHOWED NO DETECTABLE PYROGEN WHICH INDICATES, WHITH A HIGH DEGREE OF ASSURANCE THAT NO BACTERIA WERE PRESENT IN THE SOLUTIONS EITHER BEFORE OR AFTER STERILIZATION, ESPECIALLY GRAM NEGATIVE BACTERIA. ALL OF THIS EVIDENCE WOULD SUGGEST THAT UNLESS THE PACKAGES WERE COMPROMISED DURING SHIPMENT OR AT THE CLINIC, THE LISTED PD SOLUTIONS PRODUCTS ARE STERILE AS LABELED AND PROBABLE NOT RESPONSIBLE FOR ANY PERITONITIS.

Description of Event or Problem · 2

ORGANIZATION HAS EXPERIENCED AN INCREASED INFECTION RATE IN HOME PERITONEAL DIALYSIS PTS SINCE CHANGING TO FRESENIUS PRODUCTS. THIS HAS RESULTED IN TEN TOTAL EPISODES OF PERITONITIS IN FOUR PTS, OUT OF A TOTAL OF NINE PTS. FOUR EPISODES HAVE RESULTED IN HOSPITALIZATIONS, RPTR HAS A GRAPH, WHICH ILLUSTRATES THE PROBLEM DATA COLECTIONS TOOL PROVIDES MULTIPLE ASPECTS OF EVALUATION INCLUDING DATE OF ONSET, TIME PERIOD BETWEEN PRODUCT INTRODUCTION, CULTURE DATE AND PATHOGENS ISOLATED. PLEASE NOTE THE RECURRENCE OF ACINETOBACTER LWOFFI IN THREE OF THE PT'S CULTURES AS WELL AS OTHER UNUSUAL GRAM NEGAGTIVE RODS ORGANISMS. SUSPECTED MEDICAL DEVICE AND PRODUCT: FRESENIUS FREEDOM CYCLER AND PRODUCTS. HOSP STARTED THE CHANGE OVER AT THE END OF THE MONTH, WHICH CONTINUED FOR 3 MONTHS. SINCE THE NOTIFICATION OF THESE EVENTS TO INFECTION CONTROL RECOMMENDATION WAS ACCEPTED TO DISCONTINUE THE USE OF THIS SYSTEM. SINCE THE PRODUCTS ARE SHIPPED TO THE HOME BY FRESENIUS, RPTR DOES NOT HAVE THE LOT NUMBERS OF THE PD BAGS OR TUBING. THE CO HAS NOT YET PROVIDED THE SPECIFIC LOT NUMBERS (REQUESTED). RPTR HAS RECEIVED A GENERALIZED LOT NUMBER AND STERILITY OF PRODUCTS. SINCE THE TUBING MFG AND TESTING IS NOT COMPLETED BY FRESENIUS, RPTR IS STILL AWAITING THIS DOCUMENTATION. HOSP HAS COMPLETED ENVIRONMENTAL CULTURES OF THE PRODUCT IN ORGANIZATION AND HAS NOT ISOLATED ANY ORGANISMS. HOSP IS AWAITING A SHIPMENT OF THE BAXTER SYSTEM AND WILL BE CHANGING OUT THE PRODUCTS IN THE HOME. IN THE MEANTIME, THE NURSING STAFF HAS SPOKEN TO THE PTS TO REINFORCE PROCEDURE INCLUDING HAND WASHING AND THEY HAVE EVALUATED FOR ANY EXPIRED PRODUCTS. THE EXPIRATION DATES ON THE TUBING ARE CONFUSING, BEING LOCATED IN DIFFERENT PLACES DEPENDING ON THE NUMBER OF LEADS. SOME CONTAIN A LABEL ON THE FRONT OF THE FACE SHEET INSIDE THE CLEARER PACKAGE WHICH STATES THE EXIRATION DATE AND "OR 45 DAYS AFTER OPENING FOIL BAG, WHICHEVER IS FIRST" AND OTHERS HAVE IT PRINTED ON THE RIGHT EDGE OF THE PACKAGE AND THE SAME WORDING IN THE LOWER LEFT CORNER. INFECTION CONTROL HAS BEEN EDUCATED ON THE SYSTEM WHICH ACTIVATES THE PROCESS OF DIALYSIS. THE PRODUCT REQUIRES THE USER TO CLAMP IN THREE PLACES AFTER THE PROCESS IS COMPLETED AND BREAK THE TUBING LEAVING ABOUT FOUR INCHES OF DEAD SPACE, STILL FILLED WITH FLUID, CONNECTED TO THE PT UNTIL THE NEXT DIALYSIS (USUALLY EVERY EVENING). IF THE TWO CLAMPS ABOVE THIS ARE NOT CORRECTLY COMPLETED, MIGRATION OF ORGANISMS COULD OCCUR. EACH TUBING CONTAINS MALE AND FEMALE PORT(S) LOADED WITH BETADINE. RPTR HAS THE DEVICE AND PRODUCTS AVAILABLE FOR EVALUATION. AFTER THE EXCHANGE OF SYSTEMS, RPTR WILL HOUSE THE PT'S PRODUCTS WITHIN INSTITUTION UNTIL THE INVESTIGATION IS COMPLETED. ACCORDING TO MFR MORE THAN 1200 SAMPLES FROM LOTS IDENTIFIED WITH THE REFERENCED COMPLAINT HAVE SUCCESSFULLY PASSED USP STERILITY TESTING INFERRING THAT EACH LOT OF PRODUCT IS STERILE AS LABELED. DELFLEX PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE LOW MG, LOW CA. QUALITY ASSURANCE REQUIRES THE TESTING OF THREE SAMPLES (FIRST, MIDDLE AND LAST) FROM EACH LOT FOR THE PRESENCE OF BACTERIAL ENDOTOXIN (PYROGEN). THE RESULTS FROM DUPLICATE TESTING OF EACH SAMPLE BY THE KINETIC TURBIDOMETRIC LAL METHOD SHOWED NO DETECTABLE PYROGEN WHICH INDICATES, WITH A HIGH DEGREE OF ASSURANCE THAT NO BACTERIA WERE PRESENT IN THE SOLUTIONS EITHER BEFORE OR AFTER STERILIZATION, ESPECIALLY GRAM NEGATIVE BACTERIA. ALL OF THIS EVIDENCE WOULD SUGGEST THAT UNLESS THE PACKAGES WERE COMPROMISED DURING SHIPMENT OR AT THE CLINIC, THE LISTED PD SOLUTIONS PRODUCTS ARE STERILE AS LABELED AND PROBABLY NOT RESPONSIBLE FOR ANY PERITONITIS.

Description of Event or Problem · 3

ORGANIZATION HAS EXPERIENCED AN INCREASED INFECTION RATE IN HOME PERITONEAL DIALYSIS PTS SINCE CHANGING TO FRESENIUS PRODUCTS. THIS HAS RESULTED IN TEN TOTAL EPISODES OF PERITONITIS IN FOUR PTS, OUT OF A TOTAL OF NINE PTS. FOUR EPISODES HAVE RESULTED IN HOSPITALIZATIONS. RPTR HAS A GRAPH, WHICH ILLUSTRATES THE PROBLEM DATA COLLECTION TOOL PROVIDED MULTIPLE ASPECTS OF EVALUATION INCLUDING DATE OF ONSET, TIME PERIOD BETWEEN PRODUCT INTRODUCTION, CULTURE DATE AND PATHOGENS ISOLATED. PLEASE NOTE THE RECURRENCE OF ACINETOBACTER IWOFFI IN THREE OF THE PT'S CULTURES AS WELL AS OTHER UNUSUAL GRAM NEGATIVE RODS ORGANISMS. SUSPECTED MEDICAL DEVICE AND PRODUCT: FRESENIUS FREEDOM CYCLER AND PRODUCTS. HOSP STARTED THE CHANGE OVER AT THE END OF THE MONTH, WHICH CONTINUED FOR 3 MONTHS. SINCE THE NOTIFICATION OF THESE EVENTS TO INFECTION CONTROL RECOMMENDATION WAS ACCEPTED TO DISCONTINUE THE USE OF THIS SYSTEM. SINCE THE PRODUCTS ARE SHIPPED TO THE HOME BY FRESENIUS, RPTR DOES NOT HAVE THE LOT NUMBERS OF THE PD BAGS OR TUBING. THE CO HAS NOT YET PROVIDED THE SPECIFIC LOT NUMBERS (REQUESTED). RPTR HAS RECEIVED A GENERALIZED LOT NUMBER AND STERILITY OF PRODUCTS. SINCE THE TUBING MFG AND TESTING IS NOT COMPLETED BY FRESENIUS, RPTR IS STILL AWAITING THIS DOCUMENTATION. HOSP HAS COMPLETED ENVIRONMENTAL CULTURES OF THE PRODUCT IN ORGANIZATION AND HAS NOT ISOLATED ANY ORGANISMS. HOSP IS AWAITING A SHIPMENT OF THE BAXTER SYSTEM AND WILL BE CHANGING OUT THE PRODUCTS IN THE HOME. IN THE MEANTIME, THE NURSING STAFF HAS SPOKEN TO THE PTS TO REINFORCE PROCEDURE INCLUDING HAND WASHING AND THEY HAVE EVALUATED FOR ANY EXPIRED PRODUCTS. THE EXPIRATION DATES ON THE TUBING ARE CONFUSING, BEING LOCATED IN DIFFERENT PLACES DEPENDING ON THE NUMBER OF LEADS. SOME CONTAIN A LABEL ON THE FRONT OF THE FACE SHEET INSIDE THE CLEAR PACKAGE WHICH STATES THE EXPIRATION DATE AND "OR 45 DAYS AFTER OPENING FOIL BAG, WHICHEVER IS FIRST" AND OTHERS HAVE IT PRINTED ON THE RIGHT EDGE OF THE PACKAGE AND THE SAME WORKING IN THE LOWER LEFT CORNER. INFECTION CONTROL HAS BEEN EDUCATED ON THE SYSTEM WHICH ACTIVATES THE PROCESS OF DIALYSIS. THE PRODUCT REQUIRES THE USER TO CLAMP IN THREE PLACES AFTER THE PROCESS IS COMPLETED AND BREAK THE TUBING LEAVING ABOUT FOUR INCHES OF DEAD SPACE, STILL FILLED WITH FLUID, CONNECTED TO THE PT UNTIL THE NEXT DIALYSIS USUALLY EVERY EVENING). IF THE TWO CLAMPS ABOVE THIS ARE NOT CORRECTLY COMPLETED, MIGRATION OF ORGANISMS COULD OCCUR. EACH TUBING CONTAINS MALE AND FEMALE PORT(S) LOADED WITH BETADINE. RPTR HAS THE DEVICE AND PRODUCTS AVAILABLE FOR EVALUATION. AFTER THE EXCHANGE OF SYSTEMS, RPTR WILL HOUSE THE PT'S PRODUCTS WITHIN INSTITUTION UNTIL THE INVESTIGATION IS COMPLETED. ACCORDING TO MFR MORE THAN 1200 SAMPLES FROM LOTS IDENTIFIED WITH THE REFERENCED COMPLAINT HAVE SUCCESSFULLY PASSED USP STERILITY TESTING INFERRING THAT EACH LOT OF PRODUCT IS STERILE AS LABELED. DEFLEX PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE LOW MG, LOW CA. QUALITY ASSURANCE REQUIRES THE TESTING OF THREE SAMPLES (FIRST, MIDDLE AND LAST) FROM EACH LOT FOR THE PRESENCE OF BACTERIAL ENDOTOXIN (PYROGEN). THE RESULTS FROM DUPLICATE TESTING OF EACH SAMPLE BY THE KINETIC TURBIDOMETRIC LAL METHOD SHOWED NO DETECTABLE PYROGEN WHICH INDICATES, WITH A HIGH DEGREE OF ASSURANCE THAT NO BACTERIA WERE PRESENT IN THE SOLUTIONS EITHER BEFORE OR AFTER STERILIZATION, ESPECIALLY GRAM NEGATIVE BACTERIA. ALL OF THIS EVIDENCE WOULD SUGGEST THAT UNLESS THE PACKAGES WERE COMPROMISED DURING SHIPMENT OR AT THE CLINIC, THE LISTED PD SOLUTIONS PRODUCTS ARE STERILE AS LABELED AND PROBABLY NOT RESPONSIBLE FOR ANY PERITONITIS.

Description of Event or Problem · 4

ORGANIZATION HAS EXPERIENCED AN INCREASED INFECTION RATE IN HOME PERITONEAL DIALYSIS PTS SINCE CHANGING TO FRESENIUS PRODUCTS. THIS HAS RESULTED IN TEN TOTAL EPISODES OF PERITONITIS IN FOUR PTS, OUT OF A TOTAL OF NINE PTS. FOUR EPISODES HAVE RESULTED IN HOSPITALIZATIONS. RPTR HAS A GRAPH, WHICH ILLUSTRATES THE PROBLEM. DATA COLLECTION TOOL PROVIDES MULTIPLE ASPECTS OF EVALUATION INCLUDING DATE OF ONSET, TIME PERIOD BETWEEN PRODUCT INTRODUCTION, CULTURE DATE AND PATHOGENS ISOLATED. PLEASE NOTE THE RECURRANCE OF ACINETOBACTER LWOFFI IN THREE OF THE PT'S CULTURES AS WELL AS OTHER UNUSUAL GRAM NEGATIVE RODS ORGANISMS. SUSPECTED MEDICAL DEVICE AND PRODUCT: FRESENIUS FREEDOM CYCLER AND PRODUCTS. HOSP STARTED THE CHANGE OVER AT THE END OF THE MONTH, WHICH CONTINUED FOR 3 MONTHS. SINCE THE NOTIFICIATON OF THESE EVENTS TO INFECTION CONTROL RECOMMENDATION WAS ACCEPTED TO DISCONTINUE THE USE OF THIS SYSTEM. SINCE THE PRODUCTS ARE SHIPPED TO THE HOME BY FRESENIUS, RPTR DOES NOT HAVE THE LOT NUMBERS OF THE PD BAGS OR TUBING. THE CO HAS NOT YET PROVIDED THE SPECIFIC LOT NUMBERS (REQUESTED). RPTR AHS RECEIVED A GENERALIZED LOT NUMBER AND STERILITY OF PRODUCTS. SINCE THE TUBING MFG AND TESTING IS NOT COMPLETED BY FRESENIUS, RPTR IS STILL AWAITING THIS DOCUMENTATION. HOSP HAS COMPLETED ENVIRONMENTAL CULTURES OF THE PRODUCT IN ORGANIZATION AND HAS NOT ISOLATED ANY ORGANISMS. HOSP IS AWAITING A SHIPMENT OF THE BAXTER SYSTEM AND WILL BE CHANGING OUT THE PRODUCTS IN THE HOME. IN THE MEANTIME, THE NURSING STAFF HAS SPOKEN TO THE PTS TO REINFORCE PROCEDURE INCLUDING HAND WASHING AND THEY HAVE EVALUATED FOR ANY EXPIRED PRODUCTS. THE EXPIRATION DATES ON THE TUBING ARE CONFUSING, BEING LOCATED IN DIFFERENT PLACES DEPENDING ON THE NUMBER OF LEADS. SOME CONTAIN A LABEL ON THE FRONT OF THE FACE SHEET INSIDE THE CLEAR PACKAGE WHICH STATES THE EXPIRATION DATE AND "OR 45 DAYS AFTER OPENING FOIL BAG, WHICHEVER IS FIRST" AND OTHERS HAVE IT PRINTED ON THE RIGHT EDGE OF THE PACKAGE AND THE SAME WORDING IN THE LOWER LEFT CORNER. INFECTION CONTROL HAS BEEN EDUCATED ON THE SYSTEM WHICH ACTIVATES THE PROCESS OF DIALYSIS. THE PRODUCT REQUIRES THE USER TO CLAMP IN THREE PLACES AFTER THE PROCESS IS COMPLETED AND BREAK THE TUBING LEAVING ABOUT FOUR INCHES OF DEAD SPACE, STILL FILLED WITH FLUID, CONNECTED TO THE PT UNTIL THE NEXT DIALYSIS (USUALLY EVERY EVENING). IF THE TWO CLAMPS ABOVE THIS ARE NOT CORRECTLY COMPLETED, MIGRATION OF ORGANISMS COULD OCCUR. EACH TUBING CONTAINS MALE AND FEMALE PORT(S) LOADED WITH BETADINE. RPTR HAS THE DEVICE AND PRODUCTS AVAILABLE FOR EVALUATION. AFTER THE EXCHANGE OF SYSTEMS, RPTR WILL HOUSE THE PT'S PRODUCTS WITHIN INSTITUTION UNTIL THE INVESTIGATION IS COMPLETED. ACCORDING TO MFR MORE THAN 1200 SAMPLES FROM LOTS IDENTIFIED WITH THE REFERENCED COMPLAINT HAVE SUCCESSFULLY PASSES USP STERILITY TESTING INFERRING THAT EACH LOT OF PRODUCT IS STERILE AS LABELED. DELFLEX PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE LOW MG, LOW CA. QUALITY ASSURANCE REQUIRES THE TESTING OF THREE SAMPLES (FIRST, MIDDLE AND LAST) FROM EACH LOT FOR THE PRESENCE OF BACTERIAL ENDOTOXIN (PYROGEN). THE RESULTS FROM DUPICATE TESTING OF EACH SAMPLE BY THE KINETIC TURBIDOMETRIC LAL METHOD SHOWED NO DETECTABLE PYROGEN WHICH INDICATES, WITH A HIGH DEGREE OF ASSURANCE THAT NO BACTERIA WERE PRESENT IN THE SOLUTIONS EITHER BEFORE OR AFTER STERILIZATION, ESPECIALLY GRAM NEGATIVE BACTERIA. ALL OF THIS EVIDENCE WOULD SUGGEST THAT UNLESS THE PACKAGES WERE COMPROMISED DURING SHIPMENT OR AT THE CLINIC, THE LISTED PD SOLUTIONS PRODUCTS ARE STERILE AS LABELED AND PROBABLY NOT RESPONSIBLE FOR ANY PERITONITIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FRESENIUS FREEDOM CYCLER	CYCLER	KPF	FRESENIUS USA CORPORATE HEADQUARTERS	NI	NI

Patients

Seq	Age	Outcome	Treatment
1	NO INFO	Other	DELFLEX PERITONEAL DIALYSIS SOLUTION.
2	NO INFO	Hospitalization	DELFLEX PERITONEAL DIALYSIS SOLUTION.
3	NO INFO	Hospitalization	DELFLEX PERITONEAL DIALYSIS SOLUTION.
4	NO INFO	Other	DELFLEX PERITONEAL DIALYSIS SOLUTION.