MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-2000 ST

Device Problem Priming Problem (4040)

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

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer¿s site to address the reported event.Fse confirmed the complaint by reviewing the error logs and reproduced the error by running the daily check and the wash probes did not completely remove the wash from the well wash.Fse resolved the complaint by replacing the bf waste pump 2.Fse repaired and validated the analyzer by successfully performing quality control run, which passed within acceptable range.No further action required by field service.The aia-2000 analyzer is functioning as expected.The aia-2000, serial number (b)(4), was installed on (b)(6) 2022.A complaint and service history review for similar complaints was performed from installation date (b)(6) 2022through aware date (b)(6) 2022.There were no other similar complaints identified during the searched period.Aia-2000 operator's manual on the appendix 4: error messages: (2231) b/f probe 1 overflow sensor failure cause: the overflow sensor is detecting liquid continuously.Solution: clean b/f probe 1.(see chapter 9, "maintenance") if retry fails, contact tosoh service center or local representatives.(2233) b/f probe 3 overflow sensor failure cause: the overflow sensor is detecting liquid continuously.Solution: clean b/f probe 3.(see chapter 9, "maintenance") if retry fails, contact tosoh service center or local representatives.(2232) b/f probe 2 overflow sensor failure cause: the overflow sensor is detecting liquid continuously.Solution: clean b/f probe 2.(see chapter 9, "maintenance") if retry fails, contact tosoh service center or local representatives.The most probable cause of the reported event was due to the faulty bf waste pump 2.

Event Description

A customer reported error messages 2231 b/f probe 1 overflow sensor failure, 2232 b/f probe 2 overflow sensor failure, and 2233 b/f probe 3 overflow sensor failure on the aia-2000 analyzer.The 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 alpha-fetoprotein (afp).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A review of the device history record (dhr) was conducted for serial number 10651901, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported bf waste pump 2 failure.

Manufacturer Narrative

The drain pump was returned to tosoh instrument service center for investigation.Functional testing confirmed the reported event was due to failure of the waste pump.

• Brand Name: AIA-2000
• 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: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 15612991
• MDR Text Key: 307199183
• Report Number: 3004529019-2022-00174
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• 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,Followup,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000 ST
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• 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