MalfunctionMSE
F80A DIALYZER FINISHED ASSY
Received Mar 6, 2014 · Event occurred Jan 14, 2014
Report 1713747-2014-00093 · MDR key 3837856
Device
Product problems
- Fluid/Blood Leak
Patient
53 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED FROM THE HEAD OF THE DIALYZER AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 20CC'S. PT HAD NO ADVERSE EFFECTS AND REQUIRED NO MEDICAL INTERVENTION. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.