Catalog Number 10321852 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
No Patient Involvement (2645); Not Applicable (3189)
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Event Date 01/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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