MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1240 BLOOD GAS ANALYZER; RL 1240

Model Number 10321840

Device Problem Non Reproducible Results (4029)

Patient Problem Pregnancy (3193)

Event Date 07/01/2020

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.The data logs have been received for investigation.The customer stated, for the first and second samples, they did not do the necessary check of the sample to assure the sample is in the correct position.

Event Description

The customer reported discrepant ph values on the rl 1240 blood gas analyzer.The mother has undergone a caesarean section.The customer was asked to confirm the unnecessary treatment was not performed because of the discrepant results.The customer stated they used other diagnostic methods in addition, such as cardiotocography, a fetal monitor.The customer stated the baby was born in good condition.

Manufacturer Narrative

Siemens has completed the investigation.After reviewing the samples in question, it can be confirmed that the micro samples were not positioned over the pco2 and po2 sensors as they recovered close to ambient air.The observed ph discrepancy is most likely caused by blood not being positioned over the ph sensor.Micro samples on the rapid lab instruments require to be manually positioned over the reportable sensors.The instrument logs show that for the micro samples run around the time of the event, the ph, pco2 and po2 sensors were reporting in the normal range.This suggests that the sensors in question were functioning normally.

• Brand Name: RAPIDLAB 1240 BLOOD GAS ANALYZER
• Type of Device: RL 1240
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10325956
• MDR Text Key: 200509523
• Report Number: 3002637618-2020-00039
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00630414515540
• UDI-Public: 00630414515540
• Combination Product (y/n): N
• PMA/PMN Number: K073537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10321840
• Device Catalogue Number: 10321840
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1