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

Catalog Number	10492730
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abnormal Blood Gases (1034)
Date of Event	12/10/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Siemens reviewed the data files provided by the customer.The k+ sensor on rp500 sn (b)(4), cartridge sn (b)(4) was performing as intended with no system errors or disturbances around the time the suspect sample was run.Repeat analysis of the same sample provided similar k+ results on an alternate analyzer.The customer stated that there was no evidence of hemolysis.The customer is not alleging that the rp 500 result was incorrect.The cartridge is still installed on the instrument and is operational.The cause of this event is unknown.
Event or Problem Description
The customer reported a discrepant potassium result run on the rp 500 s/n (b)(4) when compared to results on a non-siemens lab analyzer, on a code patient who came into the medical center.The patient has kidney failure but had not received dialysis and they were expecting hyperkalemia.The patient was given calcium for cardiac support.A sample was drawn from a line into a lithium heparin vacuum tube and was run on the non-siemens lab analyzer at 10:25.The patient was given insulin and albuterol.A femoral artery sample was run on the rp 500 at 10:38.This same femoral artery sample was run on the non-siemens lab analyzer at 14:40.The customer was asked if an additional sample was drawn from the patient and she stated that no additional blood was drawn because the patient had died.There is no alleged harm to the patient or user due to the use of the rp 500.

• 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: 8213400
• Report Number: 3002637618-2019-00002
• Device Sequence Number: 13957253
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K122539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 58 YR