MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the complaint by reviewing the error logs and found liquid in the leak sensor.Fse could not reproduced error and did not find leak anywhere on the analyzer.Fse checked all the overflow tubes and found possible moisture in the diluent overflow tube.Fse replaced the diluent waste pump, which resolved the complaint.Fse successfully validated analyzer by performing quality control run without error and within acceptable range.No further action required by field service.The aia-900 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-900 operator's manual under section 12: flags and error messages states the following: [2009] liquid leak.Cause: leakage of solution was detected at the start of measurement, so measurement will stop.Action: please contact the tosoh local representatives.The most probable cause of the reported event was due to faulty diluent waste pump.

Event Description

A customer reported getting error message "2009 liquid leak" on the aia-900 analyzer.The customer rebooted the analyzer, but error persisted, and no leak was found.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.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette o'connell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 12291741
• MDR Text Key: 265559358
• Report Number: 8031673-2021-00224
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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