MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Suction Failure (4039)

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

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the error via the error log.The fse was able to reproduce the reported event by running test samples.Troubleshooting revealed sv171 valve intermittently not functioning correctly causing a drip to form/fluid to come out from number 2 probe tip.The fse replaced the sv171 to correct and prevent error.The fse confirmed liquid detection of probe 2 and ran washer prime many times without error.The fse ran four test samples without error.A daily check and qc was also performed successfully.The aia-900 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review for similar complaints were performed for serial number (b4) from 05apr2020 through aware date of 05may2021.There were 2 similar complaints identified during the searched period including this event.The aia-900 operator's manual under appendix 4: error messages states the following: error message: [2235] b/f probe 1 suction failure cause: the overflow sensor 1 s132 detected liquid after a water suction operation.A wu flag will be attached to the measurement result.Action: clean the wash probe 1.Check s132, the waste liquid solenoid valve sv170, the waste liquid tube, and the liquid pump lp172.The most probable cause of this reported event was due to failure of the valve.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

Customer reported an error 2235 bf probe 1 suction failure on the aia-900 analyzer.The error had occurred during a quality control run (qc).The technical support specialist (tss) verified with the customer that the wash probe tips are on and that the tubing was connected.The wash probe was cleaned well.A two-wash prime was performed and it was good.The customer had called back and the error had returned.A field service engineer was dispatched to address the reported issue which caused a delay in reporting cardiac troponin i (ctnl2) patient samples.There was 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: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 11922315
• MDR Text Key: 256498937
• Report Number: 8031673-2021-00162
• 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: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• 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: 022930111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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