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

Catalog Number 10697306

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that repeat testing was performed on another rp 500 to confirm correct results.The cause for the discrepant results is unknown.

Event Description

The customer reported discrepant sodium results.There was no report of injury due to this event.

Manufacturer Narrative

Review of instrument data files do not indicate any performance issues with the sensors around the time the discordant samples were reported.The cartridge was returned for evaluation and was installed on an internal instrument.Whole blood samples were run vs a control rp500 instrument and discordant results were observed on the returned cartridge all qcs were within published ranges.The cartridge and instrument cartridge interface frame alignment were checked and both the instrument and the cartridge were found to be out of alignment.The cartridge was disassembled and the valve seal in the luer mount was found to have a defect.In addition, during disassembly the luer mount cover came off with very little effort after the metal clips were removed; this ease of disassembly is atypical.These observations may have caused salt build up in the sample port area which may have contributed to the discordant results.

• 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: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6113267
• MDR Text Key: 60849155
• Report Number: 3002637618-2016-00153
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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