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Model Number AIA-360 IMMUNOASSAY ANALYZER |
Device Problem
Failure to Pump (1502)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A field service engineering (fse) was at the customer's site to address reported event.Fse removed cover from analyzer to find needle intact with no capped samples.Fse attempted to prime diluent to find no diluent was pumping.Fse replaced the diluent pump.No further action required by field service.The aia-360 analyzer is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no other similar complaints found during the searched period.The aia-360 operator's manual under chapter 7, section 7.1: list of error messages states the following: [2012] air detected [diluent] is generated when there is no contact with the liquid after diluent suction.The operator is instructed to contact the service department.[4017] spec.Sy clog detected is generated when a specimen clog is detected.The item is not assayed, the operator is instructed to repeat assay.[5002] no response from slave is generated when slave response not detected error.The operator is instructed to turn the power off and on again.If this problem reoccurs, contact the service department.The most probable cause of the reported event is due to failure of the diluent pump.
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Event Description
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A customer reported getting error messages "4017 spec.Sy clog detected", "2012 air detected [diluent]" and "5002 no response from the slave" on the aia-360 analyzer.Analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for intact parathyroid hormone (ipth).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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Search Alerts/Recalls
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