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

Catalog Number 10697306

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.Also stated was that in the error logs there were d2 errors for pco2 and "interfering substances detected" messages.Per the rp 500 operator's guide: "d2 excessive drift: pco2": the system turned the parameter off because the sensor exceeded calibration limits".In addition, as per the rp 500 operator's guide: "quaternary ammonium compounds (such as benzalkonium) is a known interfering substance and should be avoided.Review all cleaning solutions to determine if they contain interfering substances.The sensor contacts and the co-ox optics head assembly, which are located behind the measurement cartridge, may be damaged if they get wet.Sensors in the cartridge may be damaged if cleaning solution enters the sample port." the customer stated the measurement cartridge has been changed and they are operational.Data files have been provided for investigation.

Event Description

The customer reported discrepant pco2 results on the rp 500 when compared to the results of another rp 500.There was no report of injury due to this event.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 9526507
• MDR Text Key: 174176096
• Report Number: 3002637618-2019-00135
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1