COMBISET ACCESS FLOW REVERSE CON TWISTER

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 BIOMEDICAL TECHNICIAN REPORTED THAT THE ACCESS FLOW TWISTER ON A COMBI SET BLOODLINE SNAPPED WHILE IN USE RESULTING IN BLOOD LOSS. ADDITIONAL INFORMATION WAS PROVIDED UPON FOLLOW-UP WITH THE FACILITY ADMINISTRATOR (FA) FROM THE UNIT. THE FA REPORTED THAT ACCESS FLOW TESTING WAS BEING PERFORMED WHEN THE PRODUCT FAILURE OCCURRED. THE INCIDENT OCCURRED WITHIN THE FIRST THIRTY MINUTES OF HEMODIALYSIS (HD) TREATMENT. WHEN THE STAFF TWISTED THE TWISTER COMPONENT, IT SNAPPED AND BLOOD STARTED LEAKING OUT. THERE WERE NO MACHINE ALARMS. THERE WERE NO KNOWN CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CAUSED THE FAILURE. ONCE THE LEAK WAS IDENTIFIED, THE TREATMENT WAS IMMEDIATELY STOPPED, AND THE LINES WERE CLAMPED. THE PATIENT'S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS 250 ML. THE FA CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE COMBI SET WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. PHOTOS OF THE DEFECTIVE COMPONENT WERE PROVIDED FOR REVIEW.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR MANUFACTURER EVALUATION. ADDITIONALLY, THERE WERE NO COMPANION SAMPLES AVAILABLE AT THE DISTRIBUTION CENTERS. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. HOWEVER, PHOTOS OF THE DEFECTIVE DEVICE WERE PROVIDED FOR REVIEW. IN THE PHOTOS, IT COULD BE CONFIRMED THERE WAS A LEAK AT THE TWISTER COMPONENT. HOWEVER, THERE WERE NO CRACKS OR BROKEN COMPONENTS VISIBLE. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. IN ADDITION, THERE WAS NO ASSOCIATED REWORK RELATED TO THIS FAILURE DURING THE ASSEMBLY OF THE LOT. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. BASED ON THE PROVIDED INFORMATION, THE REPORTED COMPLAINT WAS CONFIRMED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED THAT THE ACCESS FLOW TWISTER ON A COMBI SET BLOODLINE SNAPPED WHILE IN USE RESULTING IN BLOOD LOSS. ADDITIONAL INFORMATION WAS PROVIDED UPON FOLLOW-UP WITH THE FACILITY ADMINISTRATOR (FA) FROM THE UNIT. THE FA REPORTED THAT ACCESS FLOW TESTING WAS BEING PERFORMED WHEN THE PRODUCT FAILURE OCCURRED. THE INCIDENT OCCURRED WITHIN THE FIRST THIRTY MINUTES OF HEMODIALYSIS (HD) TREATMENT. WHEN THE STAFF TWISTED THE TWISTER COMPONENT, IT SNAPPED AND BLOOD STARTED LEAKING OUT. THERE WERE NO MACHINE ALARMS. THERE WERE NO KNOWN CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CAUSED THE FAILURE. ONCE THE LEAK WAS IDENTIFIED, THE TREATMENT WAS IMMEDIATELY STOPPED, AND THE LINES WERE CLAMPED. THE PATIENT'S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS 250 ML. THE FA CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE COMBI SET WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. PHOTOS OF THE DEFECTIVE COMPONENT WERE PROVIDED FOR REVIEW.