MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the error on the error log and was able to reproduce the issue during system initiation.The fse inspected the bf syringe wash bushings and observed damaged and the bushings were in multiple pieces.As a result, the bushings were replaced.It was noted that the preventative maintenance (pm) was past due and that the bushings would have been replaced.Daily check was performed and passed without any system errors.And quality control (qc) performed was within specification.The aia-900 analyzer returned to operation.No further field action required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 06apr2019 to aware date (b)(6)2020.No other similar complaints were identified during the search period.The aia-900 operator's manual states the following: [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.The probable cause of the issue is attributed to degraded wash bushings.

Event Description

A customer reported getting multiple bf probe purge errors 2239 and 2240 during daily check on the aia-900 analyzer.The customer was unable to provide any dating information on the wash solution.As a result, the customer was advised to make fresh wash solution and prime the bf wash probes multiple times.The customer then performed ten (10) bf wash primes and daily check, but the error persisted.A field service engineer (fse) was dispatched to address the reported issue, which resulted in the delay of reporting intact parathyroid hormone (ipth) and troponin i (ctnl2) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

• 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: 10113053
• MDR Text Key: 202082517
• Report Number: 8031673-2020-00138
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930111
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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