CLIC BLOOD CHAMBER

Description of Event or Problem

THE FACILITY ADMINISTRATOR (FA) AT A USER FACILITY REPORTED THAT A BLOOD LEAK WAS OBSERVED APPROXIMATELY 10 MINUTES PRIOR TO THE COMPLETION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE FA STATED THAT THE REPORTED ISSUE WAS IDENTIFIED DURING A BLOOD PRESSURE CHECK. BLOOD WAS VISUALLY OBSERVED COMING FROM A CRACK ON THE THE CRIT-LINE CLIP (CLIC) BLOOD CHAMBER ON THE LARGER BLUE PLASTIC SCREW SIDE AND AT THE CONNECTION BETWEEN THE CLIC BLOOD CHAMBER AND THE DIALYZER. THE FA THOUGHT THE CRACK ON THE CLIC BLOOD CHAMBER WAS CAUSED BY THE DIALYZER BUT WAS NOT CERTAIN. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT ENDED TREATMENT EARLY. THE COMPLAINT DEVICES WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURERS FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

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

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 BLOODLINES 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

THE FACILITY ADMINISTRATOR (FA) AT A USER FACILITY REPORTED THAT A BLOOD LEAK WAS OBSERVED APPROXIMATELY 10 MINUTES PRIOR TO THE COMPLETION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE FA STATED THAT THE REPORTED ISSUE WAS IDENTIFIED DURING A BLOOD PRESSURE CHECK. BLOOD WAS VISUALLY OBSERVED COMING FROM A CRACK ON THE CRIT-LINE CLIP (CLIC) BLOOD CHAMBER ON THE LARGER BLUE PLASTIC SCREW SIDE AND AT THE CONNECTION BETWEEN THE CLIC BLOOD CHAMBER AND THE DIALYZER. THE FA THOUGHT THE CRACK ON THE CLIC BLOOD CHAMBER WAS CAUSED BY THE DIALYZER BUT WAS NOT CERTAIN. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT ENDED TREATMENT EARLY. THE COMPLAINT DEVICES WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURERS FOR PHYSICAL EVALUATION.