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

Model Number AIA-2000 ST

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/25/2021

Event Type  malfunction  

Event Description

A customer reported getting error messages 2239 b/f probe 1 purge failure, 2240 b/f probe 2 purge failure and 2241 b/f probe 3 purge failure on the aia-2000 instrument.The customer confirmed no liquid under the wash probes, and the wash probe tips were seated correctly and in the correct positions.Technical support specialist (tss) instructed the customer to open and close caps and reboot instrument.The customer performed a daily check run afterwards but error persisted.Tss instructed the customer to prime the wash and it completed without error.Customer adjusted the wash lines and attempted daily check run again and it passed, the customer performed quality control run and it ran without error but error reoccurred the next day.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.

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the complaint by observing the instrument functionality and reproduced error by priming wash.Fse found a small cut in tubing line at wash bottle electrode assembly pipe.Fse was able to cut out the bad section of tubing and reconnected the tubing line.Fse successfully primed wash solution and instrument functioned without error.The customer successfully ran all controls and results were within acceptable range.No further action required by field service.The aia-2000 instrument 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 three (b)(4) similar complaints identified during the searched period, which includes this event.The aia-2000 operator's manual under appendix 4: error messages states the following: [2239] b/f probe 1 purge failure cause : the overflow sensor failed to detect liquid even after the washer was purged.Solution : air may be trapped in the washer tubing.Purge any remaining air by performing the priming operation and check for the presence of air in the washer tubing.If retry fails, contact tosoh service center or local representatives.[2240] b/f probe 2 purge failure cause : the overflow sensor failed to detect liquid even after the washer was purged.Solution : air may be trapped in the washer tubing.Purge any remaining air by performing the priming operation and check for the presence of air in the washer tubing.If retry fails, contact tosoh service center or local representatives.[2241] b/f probe 3 purge failure cause : the overflow sensor failed to detect liquid even after the washer was purged.Solution : air may be trapped in the washer tubing.Purge any remaining air by performing the priming operation and check for the presence of air.The most probable cause of the reported event is due to faulty tubing.

• 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: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12818026
• MDR Text Key: 282730193
• Report Number: 3004529019-2021-00067
• 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
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1