HOME HEMO COMBI SET FOR CANADA

Description of Event or Problem

IT WAS REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING THE BLOOD RETURN PROCEDURE AT THE END OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE CLAMP ON THE SALINE LINE FAILED TO STAY CLOSED AND BLOOD REPORTEDLY SPRAYED OUT. IT WAS REPORTED THAT THE SALINE LINE DISCONNECTED. THERE WERE NO ALARMS FROM THE HD MACHINE. MINIMAL BLOOD LOSS WAS REPORTED; AN EXACT VOLUME WAS UNKNOWN. NO RE-SETUP WAS NEEDED AND THE BLOOD RETURN PROCEDURE WAS REPORTEDLY COMPLETED WITH THE SAME SET OF BLOODLINES. THERE WERE NO KNOWN ADVERSE EFFECTS OR INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED. FOLLOWING THE EVENT, THE PATIENT STATED THEY WOULD START USING BLOODLINES FROM A DIFFERENT LOT NUMBER. A PHOTO SHOWING THE FRONT OF AN HD MACHINE WITH BLOODLINES CONNECTED WAS PROVIDED FOR REVIEW. IN THE PHOTO THERE ARE VISIBLE SPLATTERS OF BLOOD UNDERNEATH THE COMBI SET TUBING. THE ACTUAL COMPLAINT DEVICE WAS DISCARDED; HOWEVER, A COMPANION SAMPLE WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR 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 OF THE COMBI SET CONNECTED TO THE MACHINE WAS PROVIDED BY THE CUSTOMER. EVIDENCE OF A BLOOD LEAK WAS APPARENT IN THE PROVIDED PHOTOGRAPH. THE PHOTOGRAPH SHOWS BLOOD LEAKING FROM THE SALINE LINE WITH THE CLOSED CLAMP. 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. DESPITE THIS, A CAUSE FOR THE REPORTED FAILURE COULD NOT BE ESTABLISHED.

Description of Event or Problem

IT WAS REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING THE BLOOD RETURN PROCEDURE AT THE END OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE CLAMP ON THE SALINE LINE FAILED TO STAY CLOSED AND BLOOD REPORTEDLY SPRAYED OUT. IT WAS REPORTED THAT THE SALINE LINE DISCONNECTED. THERE WERE NO ALARMS FROM THE HD MACHINE. MINIMAL BLOOD LOSS WAS REPORTED; AN EXACT VOLUME WAS UNKNOWN. NO RE-SETUP WAS NEEDED AND THE BLOOD RETURN PROCEDURE WAS REPORTEDLY COMPLETED WITH THE SAME SET OF BLOODLINES. THERE WERE NO KNOWN ADVERSE EFFECTS OR INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED. FOLLOWING THE EVENT, THE PATIENT STATED THEY WOULD START USING BLOODLINES FROM A DIFFERENT LOT NUMBER. A PHOTO SHOWING THE FRONT OF AN HD MACHINE WITH BLOODLINES CONNECTED WAS PROVIDED FOR REVIEW. IN THE PHOTO THERE ARE VISIBLE SPLATTERS OF BLOOD UNDERNEATH THE COMBI SET TUBING. THE ACTUAL COMPLAINT DEVICE WAS DISCARDED; HOWEVER, A COMPANION SAMPLE WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR EVALUATION.

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

IT WAS REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING THE BLOOD RETURN PROCEDURE AT THE END OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE CLAMP ON THE SALINE LINE FAILED TO STAY CLOSED AND BLOOD REPORTEDLY SPRAYED OUT. IT WAS REPORTED THAT THE SALINE LINE DISCONNECTED. THERE WERE NO ALARMS FROM THE HD MACHINE. MINIMAL BLOOD LOSS WAS REPORTED; AN EXACT VOLUME WAS UNKNOWN. NO RE-SETUP WAS NEEDED AND THE BLOOD RETURN PROCEDURE WAS REPORTEDLY COMPLETED WITH THE SAME SET OF BLOODLINES. THERE WERE NO KNOWN ADVERSE EFFECTS OR INJURIES, AND NO MEDICAL INTERVENTION WAS REQUIRED. FOLLOWING THE EVENT, THE PATIENT STATED THEY WOULD START USING BLOODLINES FROM A DIFFERENT LOT NUMBER. A PHOTO SHOWING THE FRONT OF AN HD MACHINE WITH BLOODLINES CONNECTED WAS PROVIDED FOR REVIEW. IN THE PHOTO THERE ARE VISIBLE SPLATTERS OF BLOOD UNDERNEATH THE COMBI SET TUBING. THE ACTUAL COMPLAINT DEVICE WAS DISCARDED; HOWEVER, A COMPANION SAMPLE WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: A1, A2, A3, A4 THE PLANT INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.