COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D10, H3 PLANT INVESTIGATION: ALTHOUGH THE CUSTOMER INITIALLY REPORTED THAT THE COMPLAINT SAMPLE WAS AVAILABLE TO BE RETURNED, THE COMPLAINT SAMPLE WAS NEVER RECEIVED. THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER USING A PHOTOGRAPH PROVIDED BY THE CUSTOMER WHEN THE EVENT WAS REPORTED. 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. A PRODUCT HISTORY REVIEW 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMAITON: D10, H3 PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS RETURNED TO THE MANUFACTURER FOR A PHYSICAL EVALUATION. A FUNCTIONAL TEST WAS PERFORMED, WHERE A LEAK WAS FOUND BETWEEN THE HEPARIN LINE AND THE T CONNECTOR. DURING THE PREPARATION FOR THE VISUAL INSPECTION, THE HEPARIN LINE SEPARATED FROM THE RED "T" CONNECTOR. NO SOLVENT APPLICATION WAS FOUND ON THE HEPARIN LINE TUBING AT THE RED "T" CONNECTOR PORT. THE REPORTED EVENT WAS CONFIRMED THROUGH A PHYSICAL EVALUATION OF THE SAMPLE.

Additional Manufacturer Narrative

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

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED A BLOOD LEAK THAT OCCURRED WITH A COMBISET DURING HALFWAY THROUGH A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT WAS ON A FRESENIUS 2008T MACHINE AND DIALYZING WITH A FRESENIUS DIALYZER, HOWEVER ADDITIONAL PRODUCT INFORMATION WAS NOT PROVIDED. THE BLOOD LEAK WAS VISUALLY ON THE TUBING OF THE COMBI SET. UPON CLOSER VISUAL INSPECTION, BLOOD WAS OBSERVED DRIPPING FROM THE JUNCTION PORT OF THE ACCESS FLOW TUBING WHERE THE HEPARIN LINE CONNECTS. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 30 ML. THE CM STATED THERE WERE NO LOOSE CONNECTIONS, DEFECT, OR DAMAGE FOUND ON THE COMBI SET. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT SUCCESSFULLY COMPLETED TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.