InjuryFII
MDR event
Received Jul 11, 2008
Report 9616240-2008-00038 · MDR key 1080686
Device
Product problems
- Disconnection
- Fluid/Blood Leak
- Loose or Intermittent Connection
Patient
Not reported
- Burn(s)
- Therapy/non-surgical treatment, additional
- Burn, Thermal
- Hospitalization required
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE CLINIC, THE MACHINE HAD RECEIVED A PREVENTIVE MAINTENANCE OVER THIRTEEN MOS PRIOR TO THE EVENT. 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 PRESENTED WITH PLASTIC "TIE-WRAP" RATHER THAN A METAL CLIP SECURING THE TUBING ONTO ONE OF THE MALE CONNECTOR ASSEMBLIES. REPLACEMENT METAL CLIPS HAVE BEEN ORDERED.