GAMBRO
Received Jun 13, 2008 · Event occurred Mar 26, 2008
Report 1713683-2008-00001 · MDR key 1061123
Device
Generic name
Hemodialysis Machine
Manufacturer
GambroModel number
CENTRYSYSTEM 3Catalog number
333100001
Lot number
UNK
Product problems
- Output, low
Patient
65 YR
- Treatment with medication(s)
- Weight Changes
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT WHILE A PT WAS ON A CENTRYSYSTEM 3 MACHINE, THE MACHINE PULLED TOO MUCH FLUID FROM THE PATIENT. THE TARGET WEIGHT REMOVAL WAS SET FOR 1.9 KG. ACTUAL WEIGHT REMOVAL WAS CHARTED AT 3.3 KG, WHEN THE PATIENT WAS WEIGHED AFTER TREATMENT. THE PATIENT WAS RETURNED TO THE TREATMENT AREA AND WAS GIVEN 1.5 LITERS OF SALINE IV. HER VITALS STABILIZED AND SHE WAS DISCHARGED HOME WITHOUT FURTHER INTERVENTION OR TREATMENT.
Additional Manufacturer Narrative
THE DEVICE WAS INSPECTED. A SILICONE PLUG WAS FOUND IN VALVE 7 AND WAS REMOVED. THE PLUG BECAME DISLODGED FROM WITHIN THE BALANCE CHAMBER DIAPHRAGM AND TRAVELED DOWNSTREAM, CAUSING VB7 TO LEAK. FAILURE TO VB7 TO COMPLETELY CLOSE CAN RESULT IN UNMONITORED FLUID REMOVAL FROM THE PATIENT. THE TECHNICIAN PROCEEDED TO FUNCTIONALLY TEST THE MACHINE AND FOUND IT TO BE WORKING WITHIN MANUFACTURER'S SPECIFICATIONS.