MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Mechanical Problem (1384)

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

Event Date 06/05/2020

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.The issue was resolved by replacing the wash heater.Instrument performance validation was performed via quality control (qc).Qc results passed within the customer ranges.The aia-360 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 (b)(6) 2019 to aware date (b)(4) 2020.No other similar complaints were identified during the search period.The aia-360 operator's manual states the following: [3003] waiting for temperature.Description: waiting for the temperature to rise.Troubleshooting: wait until the temperature rises to correct temperature.[3004] temperature timeout description: a timeout error occurred while waiting for the temperature to rise.Troubleshooting: turn the power off and on again.If this problem reoccurs, contact the service department.The probable cause is attributed to faulty wash heater.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A customer reported receiving error 3003 waiting for temperature, and 3004 temperature timeout on the aia-360 analyzer.The customer attempted to resolve the issue, but the errors continued to appear.An fse was dispatched.A field service engineer (fse) was dispatched to address the reported issue, which resulted in the delay of reporting beta-human chorionic gonadotropin (bhcg) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

Manufacturer Narrative

Device evaluation: the suspect heater unit was returned to tosoh instrument service center for investigation.A visual inspection revealed no shipping damage.Inspection revealed large amount of rust damage around the input (tygon) tube fitting.Functional testing was performed by attempting to push fluid into the port of the heater using syringe and deionized water.The tube was partially blocked with rusty colored contaminants.The contaminants caused back pressure which was relieved when the fluid got past the tygon tubing zip tie.The heater unit failed.

• Brand Name: AIA-360
• Type of Device: AIA-360
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 10218756
• MDR Text Key: 200470832
• Report Number: 8031673-2020-00164
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1