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

Model Number 10492730

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/06/2020

Event Type  malfunction  

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 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
• 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: 10609889
• MDR Text Key: 209395784
• Report Number: 3002637618-2020-00051
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00630414589169
• UDI-Public: 00630414589169
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10492730
• Device Catalogue Number: 10492730
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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