MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused, or contributed to the event.A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed reported error by reviewing the analyzer printouts, and reproduced the error by performing a wash prime.Fse inspected the bf wash delivery system, and found the wash syringe bushings and seal were broken.Fse resolved the reported event by replacing the wash syringe.Fse performed a quality control run, which completed 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: [2239] bf probe 1 purge failure cause: the overflow sensor 1 s132 failed to detect liquid after the washer was discharged.Action: it is conceivable that air has entered the washer tube.Prime the tube and bleed off the air.Check the remaining quality of washer, check to see if there is air in the washer tube, and check s132, the discharge solenoid valve sv150, and the washer tube.[2240] bf probe 2 purge failure: cause: the overflow sensor 2 s133 failed to detect liquid after the washer was discharged.Action: it is conceivable that air has entered the washer tube.Prime the tube and bleed off the air.Check the remaining quality of washer, check to see if there is air in the washer tube, and check s133, the discharge solenoid valve sv151, and the washer tube.[2105] diluent suction error: cause: the tip did not touch the liquid level during suction of the diluent.A retry will be carried out, and if there is no improvement a ds flag will be attached to the measurement result.Action: if the trouble reoccurs, contact the tosoh local representatives.Check the diluent, the adjustment of the suction position, the liquid level detection sensor s053, the liquid level detection operation, and also the liquid level detection sensitivity.The most probable cause of the reported event was due to component faulty wash syringe.

Event Description

A customer reported getting error messages ,"2239 bf probe 1 purge failure and 2240 bf probe 2 purge failure" when priming wash and diluent on the aia-900 analyzer.The customer also reported error "2105 diluent suction error," occurred while attempting to troubleshoot.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient sample for cardiac troponin i (ctnl2).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 oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10663519
• MDR Text Key: 210914855
• Report Number: 8031673-2020-00305
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• 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: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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