MDR event
Received Jul 11, 2008
Report 9616240-2008-00036 · MDR key 1080688
Device
Product problems
- Break
- Disconnection
- Fluid/Blood Leak
- Material Separation
Patient
Not reported
- Burn(s)
- Therapy/non-surgical treatment, additional
- Burn, Thermal
- Hospitalization required
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE CLINIC, SEVEN WEEKS BEFORE THE EVENT, THE LOCAL TECHNICIAN PERFORMED A PREVENTIVE MAINTENANCE ON THE PHOENIX MACHINE REPLACING THE ACID/ACETATE, THE BIOCARBONATE MALE AND FEMALE CONCENTRATE CONNECTORS. THE HOSPITAL HAS SIXTY-SIX PHOENIX MACHINES LOCATED IN THREE AFFILIATED UNITS. ALL OF THE MACHINES HAVE BEEN INSPECTED BY THE LOCAL TECHNICIAN IN ORDER TO VERIFY THAT THE CONCENTRATE LINES WERE SECURELY ATTACHED TO THE CONCENTRATE CONNECTORS. THREE MACHINES WERE PRESENTED WITH PLASTIC "TIE-WRAP" RATHER THAN A METAL CLIP SECURING THE TUBING ONTO ONE OF THE MAPLE CONNECTOR ASSEMBLIES. REPLACEMENT METAL CLIPS HAVE BEEN ORDERED.