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

Catalog Number	11416751
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they received a discrepant hco3 result (which is calculated from pco2 and ph) on one patient compared to retesting of different samples on the same instrument and another rp500e instrument.Customer stated that the patient's ventilator settings were adjusted based on the incorrect results but that there was no harm and patient is stable.
Additional Manufacturer Narrative
Siemens has shown due diligence in attempting to receive more information and the instrument files from the customer to perform an investigation.However, the customer has not responded.Therefore, no further investigation is possible.The cause of this event is unknown.
Additional Manufacturer Narrative
A review of the instrument files provided by the customer showed that the measurement cartridge was performing as intended.There were no r1 files to thoroughly investigate the customer¿s issue.Internal quality checks verify that the ph sensor results reported are accurate.However, a confirmation isn¿t possible due to the r1 file for the event day isn¿t available.On the day of the event, all three levels of aqc for the ph sensor was found to be either at the specification limits or out of specification.There were also d2 excessive drift errors before the sample in question was run.All the aqc recoveries transitioned from values at or beyond the specification limits to those more closely aligned with the median of the acceptable range and the d2 errors were cleared prior to running the sample in question.It should be noted the escalated sample was measured about 1 hour prior to the other two sample measurements.The cause of this event is unknown.

• Brand Name: RAPIDPOINT 500E BLOOD GAS SYSTEM
• Common Device Name: RP 500E
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 20048668
• Report Number: 3002637618-2024-00087
• Device Sequence Number: 7934049
• Product Code: CHL
• UDI-Device Identifier: 00630414286143
• UDI-Public: 00630414286143
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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 Catalogue Number: 11416751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Male