CLIC BLOOD CHAMBER

Description of Event or Problem

A USER FACILITY REPORTED TO FRESENIUS VIA VOLUNTARY MEDWATCH # (B)(4) THAT A BLOOD LEAK OCCURRED WITH A CRIT-LINE CLIP (CLIC) BLOOD CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS CAUGHT IMMEDIATELY BY THE STAFF. THE MACHINE, A FRESENIUS 2008T HD SYSTEM, DID NOT ALARM. IT WAS REPORTED THAT THE CLIC BLOOD CHAMBER SEPARATED INTO TWO PARTS. THE BLUE SENSOR DISCONNECTED FROM THE PART THAT CONNECTS WITH THE DIALYZER. THE PATIENT WAS UTILIZING A FRESENIUS DIALYZER AND FRESENIUS BLOODLINES. IT WAS CONFIRMED THAT THE DIALYZER AND BLOODLINES HAD NOT MALFUNCTIONED IN ANY WAY. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE CLIC BLOOD CHAMBER PRIOR TO THE EVENT. THERE WERE NO LOOSE CONNECTIONS OR ISSUES ENCOUNTERED DURING PRIME. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT WAS COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER 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

H3 PLANT INVESTIGATION: THE USER FACILITY RETURNED COMPLAINT SAMPLES TO THE MANUFACTURER FOR PHYSICAL EVALUATION. 74 SAMPLES WERE RECEIVED IN THEIR ORIGINAL PACKAGING WITH PRODUCT NUMBER CL10041021 AND LOT NUMBER 21KR01001. DURING VISUAL INSPECTION OF THE RETURNED SAMPLES, A SEPARATION WAS NOTICED IN 9 OF THE SAMPLES BETWEEN THE CLIC PORT AND THE DIN CONNECTOR. NO SOLVENT WAS FOUND ON THESE SAMPLES. THE DIN CONNECTOR AND THE CLIC BODY PORT WERE DIMENSIONALLY INSPECTED AND WERE FOUND TO BE ACCEPTABLE. THIS KIND OF FAILURE COULD BE ATTRIBUTED TO A MALFUNCTIONING OF THE MACHINE THAT PERFORMS THE ASSEMBLY OF THE PRODUCT, BY SEVERAL DIFFERENT CAUSES. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. BASED ON THE SAMPLE EVALUATION THAT WAS PERFORMED, THE ALLEGED FAILURE MODE WAS ABLE TO BE CONFIRMED.

Description of Event or Problem

A USER FACILITY REPORTED TO FRESENIUS VIA VOLUNTARY MEDWATCH # (B)(4) THAT A BLOOD LEAK OCCURRED WITH A CRIT-LINE CLIP (CLIC) BLOOD CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS CAUGHT IMMEDIATELY BY THE STAFF. THE MACHINE, A FRESENIUS 2008T HD SYSTEM, DID NOT ALARM. IT WAS REPORTED THAT THE CLIC BLOOD CHAMBER SEPARATED INTO TWO PARTS. THE BLUE SENSOR DISCONNECTED FROM THE PART THAT CONNECTS WITH THE DIALYZER. THE PATIENT WAS UTILIZING A FRESENIUS DIALYZER AND FRESENIUS BLOODLINES. IT WAS CONFIRMED THAT THE DIALYZER AND BLOODLINES HAD NOT MALFUNCTIONED IN ANY WAY. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE CLIC BLOOD CHAMBER PRIOR TO THE EVENT. THERE WERE NO LOOSE CONNECTIONS OR ISSUES ENCOUNTERED DURING PRIME. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT WAS COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H3 PLANT INVESTIGATION: ALTHOUGH A SAMPLE WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION, TO DATE NO SAMPLE HAS BEEN RECEIVED AND A PHYSICAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, A PHOTOGRAPH WAS RECEIVED FROM THE CUSTOMER WHICH SHOWS A SEPARATION FROM THE BLUE CHAMBER BODY CONNECTION TO THE DIN CONNECTOR. THIS KIND OF FAILURE MODE COULD BE ATTRIBUTED TO ANY OF THE FOLLOWING: A MALFUNCTIONING OF THE MACHINE THAT PERFORMS THE ASSEMBLY (BY NOT APPLYING THE SOLVENT ON THE DIN CONNECTOR), A DRYNESS CHANNEL, THE DIN CONNECTOR NOT BEING ASSEMBLED TO THE CHAMBER BODY, OR THE DIN CONNECTOR ASSEMBLED WITH A GAP GREATER THAN THE SPECIFICATION. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED BASED ON THE PROVIDED PHOTOGRAPH.

Description of Event or Problem

A USER FACILITY REPORTED TO FRESENIUS VIA VOLUNTARY MEDWATCH#: (B)(4) THAT A BLOOD LEAK OCCURRED WITH A CRIT-LINE CLIP (CLIC) BLOOD CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS CAUGHT IMMEDIATELY BY THE STAFF. THE MACHINE, A FRESENIUS 2008T HD SYSTEM, DID NOT ALARM. IT WAS REPORTED THAT THE CLIC BLOOD CHAMBER SEPARATED INTO TWO PARTS. THE BLUE SENSOR DISCONNECTED FROM THE PART THAT CONNECTS WITH THE DIALYZER. THE PATIENT WAS UTILIZING A FRESENIUS DIALYZER AND FRESENIUS BLOODLINES. IT WAS CONFIRMED THAT THE DIALYZER AND BLOODLINES HAD NOT MALFUNCTIONED IN ANY WAY. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE CLIC BLOOD CHAMBER PRIOR TO THE EVENT. THERE WERE NO LOOSE CONNECTIONS OR ISSUES ENCOUNTERED DURING PRIME. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT WAS COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.