Model Number 11416751 |
Device Problem
No Device Output (1435)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/16/2022 |
Event Type
malfunction
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Event Description
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The customer reported that the patient sample clotted their rp500e analyzer and therefore a blood gas result could not be obtained during a code.The patient died.Safety data information from the complaint states that the customer is not alleging that the cause was related to an instrument malfunction or harm to the patient was due to the use of the device.
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Manufacturer Narrative
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The customer stated that the same sample was used on this and another rp00e instrument and clotted both.The instrument event log shows multiple obstruction errors.Siemens has requested more information and instrument log files for further investigation.This mdr is being filed out of an abundance of caution due to the information from the customer stating that the patient is deceased.
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Manufacturer Narrative
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Siemens has shown due diligence in attempting to receive more information from the customer however, the customer has not been able to provide the requested information.Instrument log files were not returned and therefore no further investigation can be performed.The customer did state that the cause of the clot was due to the use of a non-heparinized syringe.The customer is not alleging that the rp500e instrument caused or contributed to the death of the patient.
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Search Alerts/Recalls
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