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

Catalog Number 10321852

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); Not Applicable (3189)

Event Date 01/07/2018

Event Type  malfunction  

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 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.

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
• Type of Device: RL 1265
• 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: 7213431
• MDR Text Key: 98068272
• Report Number: 3002637618-2018-00008
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00630414515571
• UDI-Public: 00630414515571
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K073537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10321852
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• 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