MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500E BLOOD GAS SYSTEM; RP 500E

Catalog Number 11416755

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

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 customer has provided instrument files and the investigation is underway.The cause of this event is unknown.

Event Description

The customer received several discrepant high po2 results on the rp 500e when compared to retesting of new samples on another rp 500e.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation: data from the customer's rp500e systems s/n (b)(6) were reviewed.The po2 sensor on system (b)(6), appears to be functioning as intended.There is no evidence that the po2 was malfunctioning.The po2 sensors had no d2 drift error or d3 slope errors on either rp500e systems.Aqc results were all within value assignment limits.The discrepancy may be due to an air bubble.The pairs of samples were always taken from same syringe and in each case the original sample was run rp500e (b)(6) followed by rp500e (b)(6).When a syringe is run on the rapidpoint systems, air is pulled into the syringe to replace the blood that was pulled into the system.If the air bubble is not expelled, the po2 readings will increase as it equilibrates with air.The co-ox oxyhemoglobin results also increase as did the po2 sensor giving a higher result for the sample run at 8:12 am, 9:56am and 9:59 am.Since the oxyhemoglobin result on system (b)(6) was also higher than system (b)(6), this indicates the o2 sensor was responding to the oxygen present in the sample.The root cause of this event is unknown.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Type of Device: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11021041
• MDR Text Key: 223476106
• Report Number: 3002637618-2020-00072
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K192240
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11416755
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 99 YR