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

Model Number	10492730
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Codes	Increased Intra-Peritoneal Volume (IIPV) (4498); Renal Impairment (4499)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation completed: review of the rp 500 instrument s/n 39970 data files show that over the life of the cartridge, the instrument detected a quaternary ammonium compound several times which is a sodium sensor interference, as described in rp500 operator manual; substances like benzalkonium chloride and chlorhexidine are not recommended.The exposure to these types of compounds destabilizes the sodium sensor and results with sensor drift and slope errors.Some disinfectant/exterior cleaners and skin puncture site disinfectants, particularly containing quaternary ammonium compounds (qac), are known to affect sodium as described in the rp500 operator's guide (rev 2) and customer bulletin 2018-10 (cust-00445-edg).The magnitude of the effect is based on the amount of the material drawn in with the blood during syringe sample collection or at the sample luer area.The customer stated they changed the measurement cartridge and have not had any additional discrepant na results.They have educated the staff about using the proper cleaning agents.This mdr is being filed with an abundance of caution due to the fact that the customer stated there were two or procedures that were delayed.
Event or Problem Description
The customer reported discrepant low sodium results on two patients run on the rp 500 when compared to a non-siemens lab instrument.The customer stated that both patients had delayed or procedures due to the low results.Patient #1, delayed procedure: laparoscopic peritoneal dialysis catheter with remote extension with exit on chest.Patient #2, delayed procedure: transurethral resection of bladder tumor.Both procedures were delayed for approximately one hour.There was no injury to the patients due to this event.

• 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: 10775055
• Report Number: 3002637618-2020-00061
• Device Sequence Number: 13734771
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K122539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/02/2020

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 Model Number: 10492730
• Device Catalogue Number: 10492730
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1