COMBISET BLOODLINE

Description of Event or Problem

A USER FACILITY REGISTERED NURSE (RN) REPORTED A PATIENT HEMODIALYSIS (HD) MACHINE WAS ALARMING AND NOTED BY STAFF THAT THERE WAS BLOOD COMING OUT FROM THE TOP OF THE VENOUS CHAMBER AND WHEN CHECKING, ONE OF THE TUBING THAT SUPPOSED TO BE ATTACHED TO VENOUS CHAMBER WAS DISCONNECTED. UPON FOLLOW-UP, THE CLINIC MANAGER (CM) STATED A HEMODIALYSIS (HD) PATIENT WAS ONE HOUR A THREE MINUTES INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN THE MACHINE PROMPTED AN ALARM INDICATING AIR IN THE LINE, AND STAFF NOTICED BLOOD LEAKING FROM THE VENOUS PIGTAIL ACCESS SITE. TREATMENT WAS HALTED AND THE STAFF REPORTED THE PIGTAIL COMPONENT HAD COMPLETELY DETACHED FROM THE TUBING AND REMAINING COMBISET. THE CM STATED THE ACCESS SITE HAD NOT BEEN USED DURING THE PATIENT TREATMENT AND PRIOR TO THE REPORTED EVENT. A FRESENIUS DIALYZER WAS USED FOR TREATMENT AND THE ARTERIAL SIDE OF THE PATIENT'S BLOOD WAS RETURNED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 100 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE MACHINE WAS NOT REMOVED FROM THE FLOOR AND REMAINED IN SERVICE. FOLLOWING THE EVENT, THE CM STATED THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH A NEW DIALYZER AND TUBING LINES WITHOUT FURTHER ISSUE. THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE SAMPLE WAS RECEIVED IN PACKAGING DIFFERENT FROM THE STANDARD CONFIGURATION. THE SAMPLE WAS DISINFECTED. AS THE COMPLAINT PRODUCT SAMPLE WAS BEING DISINFECTED AND PREPARED FOR ANALYSIS, A LEAK WAS FOUND ON THE TOP CAP OF THE VENOUS CHAMBER DUE TO A DETACHMENT FROM THE MAIN LINE TO THE PORT OF THE TOP CAP. AFTER FURTHER INSPECTION, NO OTHER PROBLEMS WERE FOUND. A VISUAL INSPECTION WAS PERFORMED, DURING THE INSPECTION A SEPARATION BETWEEN THE VENOUS MAIN LINE AND THE TOP CAP CHAMBER WAS OBSERVED. MICROSCOPIC INSPECTION REVEALED SOLVENT ON THE TUBE AND ON THE PORT OF THE CHAMBER. AFTER FURTHER INSPECTION, NO OTHER ISSUES WERE FOUND IN THE REMAINING COMPONENTS OF THE SET. THE REPORTED ISSUE WAS CONFIRMED DURING THE EVALUATION. REFER TO ATTACHMENT A FOR THE FULL INVESTIGATION REPORT. POTENTIAL ROOT CAUSES: THE OBSERVED DAMAGE MAY BE ATTRIBUTED TO IMPROPER ASSEMBLY DURING THE MANUFACTURING PROCESS. POSSIBLE CONTRIBUTING FACTORS INCLUDE: DISPENSERS NOT APPROPRIATELY WORKING IN THE ASSEMBLY PROCESS LACK OF SOLVENT IN DISPENSER SOLVENT APPLICATION TECHNIQUE UNQUALIFIED OPERATOR UNCLEAR WORK INSTRUCTION INCORRECT DISPENSER CONFIGURATION. 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 AND REVEALED NO DOCUMENTED NON-CONFORMANCES, DEVIATIONS, OR REWORK ACTIVITIES ASSOCIATED WITH THE COMPLAINT DESCRIPTION. UPON COMPLETION OF THE EVALUATION, THE REPORTED EVENT WAS CONFIRMED.

Description of Event or Problem

A USER FACILITY REGISTERED NURSE (RN) REPORTED A PATIENT HEMODIALYSIS (HD) MACHINE WAS ALARMING AND NOTED BY STAFF THAT THERE WAS BLOOD COMING OUT FROM THE TOP OF THE VENOUS CHAMBER AND WHEN CHECKING, ONE OF THE TUBING THAT SUPPOSED TO BE ATTACHED TO VENOUS CHAMBER WAS DISCONNECTED. UPON FOLLOW-UP, THE CLINIC MANAGER (CM) STATED A HEMODIALYSIS (HD) PATIENT WAS ONE HOUR A THREE MINUTES INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN THE MACHINE PROMPTED AN ALARM INDICATING AIR IN THE LINE, AND STAFF NOTICED BLOOD LEAKING FROM THE VENOUS PIGTAIL ACCESS SITE. TREATMENT WAS HALTED AND THE STAFF REPORTED THE PIGTAIL COMPONENT HAD COMPLETELY DETACHED FROM THE TUBING AND REMAINING COMBISET. THE CM STATED THE ACCESS SITE HAD NOT BEEN USED DURING THE PATIENT TREATMENT AND PRIOR TO THE REPORTED EVENT. A FRESENIUS DIALYZER WAS USED FOR TREATMENT AND THE ARTERIAL SIDE OF THE PATIENT'S BLOOD WAS RETURNED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 100 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE MACHINE WAS NOT REMOVED FROM THE FLOOR AND REMAINED IN SERVICE. FOLLOWING THE EVENT, THE CM STATED THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH A NEW DIALYZER AND TUBING LINES WITHOUT FURTHER ISSUE. THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative

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