CLIC BLOOD CHAMBER

Description of Event or Problem

A USER FACILITY MEDICAL DIRECTOR REPORTED A BLOOD LEAK ON THE CLIC BLOOD CHAMBER DURING TREATMENT. UPON FOLLOW UP, THE MEDICAL DIRECTOR COULD NOT CONFIRM HOW LONG INTO TREATMENT THE BLOOD LEAK OCCURRED. THE MEDICAL DIRECTOR REPORTED THAT THE LEAK WAS VISUALLY OBSERVED IN THE MIDDLE OF THE CLIC BLOOD CHAMBERS NOT NEAR THE CONNECTION TO THE DIALYZER OR BLOOD LINES. THE MEDICAL DIRECTOR STATED THAT THE PATIENT WAS ON AN OUTSET TABLO MACHINE (SERIAL NUMBER AND CATALOG NUMBER UNKNOWN) AND USING A BAXTER REVACLEAR DIALYZER (PRODUCT NUMBER AND LOT NUMBER UNKNOWN) WITH OUTSET TABLO BLOODLINES (PRODUCT NUMBER AND LOT NUMBER UNKNOWN). THE MEDICAL DIRECTOR CONFIRMED THE PATIENT WAS ABLE TO COMPLETE TREATMENT USING THE SAME MACHINE AND SUPPLIES WITHOUT THE BLOOD CHAMBER ATTACHED. THE MEDICAL DIRECTOR STATED THAT THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. THE MEDICAL DIRECTOR CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTIONS REQUIRED AS A RESULT OF THE EVENT. THE MEDICAL DIRECTOR REPORTED THAT THERE WERE NO CHANGES IN THE BLOOD FLOW RATE (BFR). THE MEDICAL DIRECTOR CONFIRMED THAT THE SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER IT WAS NOT AVAILABLE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE CUSTOMER FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL FRESENIUS CLIC BLOOD CHAMBERS SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.

Description of Event or Problem

A USER FACILITY MEDICAL DIRECTOR REPORTED A BLOOD LEAK ON THE CLIC BLOOD CHAMBER DURING TREATMENT. UPON FOLLOW UP, THE MEDICAL DIRECTOR COULD NOT CONFIRM HOW LONG INTO TREATMENT THE BLOOD LEAK OCCURRED. THE MEDICAL DIRECTOR REPORTED THAT THE LEAK WAS VISUALLY OBSERVED IN THE MIDDLE OF THE CLIC BLOOD CHAMBERS NOT NEAR THE CONNECTION TO THE DIALYZER OR BLOOD LINES. THE MEDICAL DIRECTOR STATED THAT THE PATIENT WAS ON AN OUTSET TABLO MACHINE (SERIAL NUMBER AND CATALOG NUMBER UNKNOWN) AND USING A BAXTER REVACLEAR DIALYZER (PRODUCT NUMBER AND LOT NUMBER UNKNOWN) WITH OUTSET TABLO BLOODLINES (PRODUCT NUMBER AND LOT NUMBER UNKNOWN). THE MEDICAL DIRECTOR CONFIRMED THE PATIENT WAS ABLE TO COMPLETE TREATMENT USING THE SAME MACHINE AND SUPPLIES WITHOUT THE BLOOD CHAMBER ATTACHED. THE MEDICAL DIRECTOR STATED THAT THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. THE MEDICAL DIRECTOR CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTIONS REQUIRED AS A RESULT OF THE EVENT. THE MEDICAL DIRECTOR REPORTED THAT THERE WERE NO CHANGES IN THE BLOOD FLOW RATE (BFR). THE MEDICAL DIRECTOR CONFIRMED THAT THE SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER IT WAS NOT AVAILABLE.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.