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

Model Number	10492730
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that the operator was wearing gloves.The sample port is not available to be returned for investigation.The operator stated that the sample port appeared to be clean.The system is designed so that there is no carry-over between each sample through calibration wash cycles which helps minimize exposure.The system washes after every sample to aid in keeping the system clean and decrease and minimize any biohazard exposure.The customer stated the operator is doing well.No further information or details provided.
Event or Problem Description
The customer reported that the operator states that he tried to replace a measurement cartridge in the rp 500 and noticed a door error and electronic error.He then tried to push the door shut and noticed his right hand, index finger, punctured the sample port needle.He immediately bled out the cut and followed occupational health procedures and policies and went to the er to get treated.

• 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: 10609889
• Report Number: 3002637618-2020-00051
• Device Sequence Number: 16432029
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: 09/06/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1