MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265 BLOOD GAS ANALYZER; RL 1265

Catalog Number	10321852
Health Effect - Clinical Codes	No Patient Involvement (2645); Not Applicable (3189)
Date of Event	01/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that the instrument didn't give any fluid errors, and specifically no d23 errors (reagent flow errors).They also stated that calibrations were correct and the qc were in the expected ranges.Siemens requested that the cartridge and the equipment files be sent back for investigation.They installed a new reagent cartridge and stated the instrument is fully functional.
Event or Problem Description
The customer reported fluid leakage below the reagent cartridge of the rl 1265 blood gas analyzer which was a combination of reagents and blood.The customer stated the operator was wearing protective clothing and gloves and there was no skin exposure.There was no report of injury due to this event.
Additional Manufacturer Narrative
Siemens received the reagent cartridge that was requested to be returned.Results of the investigation: on the outside of the cartridge there were no signs of damage and all parts were assembled correctly.The waste nozzle was spotless with no signs that the reagent had been passed through it.While removing the cover, it was clear that blood and reagent had leaked into the cartridge.The waste tube became disconnected after manufacturing completed release testing and either before or early on initialization of the cartridge by the customer.The cause of the tube being disconnected could not be determined.

• Brand Name: RAPIDLAB 1265 BLOOD GAS ANALYZER
• Common Device Name: RL 1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7213431
• Report Number: 3002637618-2018-00008
• Device Sequence Number: 136067
• Product Code: CHL
• UDI-Device Identifier: 00630414515571
• UDI-Public: 00630414515571
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K073537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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: 10321852
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1