MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-900

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed in response to a complaint of error 2239 bf probe 1 purge failure on the aia-900 analyzer.Technical support received the call from the customer and dispatched field service without further troubleshooting.It is not known whether the device was being used for treatment or diagnosis at the time of the complaint.At the customer site, field service confirmed the complaint by review the error log then was able to reproduce the errors by running blood samples.A leak was noted.This indicates a leakage or seal problem due to component failure.The wash probe assembly exhibited leakage/ seal problems due to component failure.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 20aug2020 through aware date 20sep2021.There was one similar complaint identified during the search period.The aia-900 operator¿s manual section 12.Flags and error messages 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.

Event Description

The customer called to report that they are getting a constant error 2239 bf probe 1 purge failure on the aia-900 analyzer.Technical service had the customer run multiple bf wash primes, inspect the wash container tubing however the error persisted.The analyzer is down.Field service was dispatched to address the reported event which resulted in delayed reporting of patient results for human chorionic gonadotropin (total beta), estradiol, and luteinizing hormone.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: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12666074
• MDR Text Key: 277717643
• Report Number: 3004529019-2021-00051
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• 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: 022930
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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