AQUARIUS HAEMOFILTRATION MACHINE
Received Aug 21, 2008 · Event occurred Jul 8, 2008
Report 6000002-2008-08492 · MDR key 1137264
Device
Generic name
Haemofiltration Machine
Manufacturer
Edwards LifesciencesModel number
GEF09500Catalog number
NA
Lot number
NA
Product problems
- Failure to Pump
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
REPORTEDLY, THE DOCTOR'S CLAMP LINE CITRATE ALARM REPETITIVE (EVERY 6 MINUTES). AFTER SEVERAL REVIVALS OF THE TREATMENT, DETERMINED A CRITICAL INCREASE OF CALCEMIA OF THE PATIENT. OBVIOUSLY, THE CITRATE PUMP DID NOT TURN CALCIUM IN A NORMAL MANNER CONTRARY TO THE PUMP. THE TREATMENT HAS BEEN STOPPED. THE MACHINE COULD BE REUSED WITHOUT PUMPS RCA. ANTI COAGULATION BEING ACCOMPLISHED WITH THE AID OF EXTERNAL PUMPS. PATIENT EXPERIENCED CRITICAL INCREASE OF CALCEMIA WITHOUT RHYTHM DISORDERS.
Additional Manufacturer Narrative
DEVICE NOT YET EVALUATED.