MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500 BLOOD GAS ANALYZER; RP 500

Catalog Number	10492730
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Common Device Name: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7604961
• Report Number: 3002637618-2018-00068
• Device Sequence Number: 11111891
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1