Catalog Number 10492730 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/19/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.The data logs have been requested for investigation.The customer stated they are operational and the measurement cartridge is not available to be returned.The cause of this event is unknown.
|
|
Event Description
|
The customer reported that an anesthesiologist was questioning a sodium result on the rp 500 (s/n (b)(4)) during a liver transplant.A total of 23 blood gases were run during the procedure.The sodium values were all in the range of 119 - 124 mmol/l except for one questionable result which was 137 mmol/l.The anesthesiologist asked for another rp 500 (s/n (b)(4)) to be brought to the operating room.The second rp 500 (s/n (b)(4)) was used for the remainder of the procedure.There was no report of injury due to this event.
|
|
Manufacturer Narrative
|
Siemens evaluated the data provided by the customer.Review of the instrument data files do not indicate any performance issues with the sensors around the time the discordant samples were reported.There were no fluidic, sensor or system errors immediately preceding the suspect result.The r1 files and the measurement cartridge were not provided so additional investigation cannot be performed.The cause of this event is unknown.
|
|
Search Alerts/Recalls
|