MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problems Suction Problem (2170); Suction Failure (4039)

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

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed and reproduced the error by running a bf wash probe prime.Further troubleshooting steps revealed that there was a clot in the suction part of the bf probe.The fse removed the clot reran the wash prime with no system errors.Instrument validation was performed via quality control (qc).Qc results passed within the laboratory ranges.The aia-900 instrument returned to normal 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)(6) 2020.No other similar complaints were identified during the search period.The aia-900 operator's manual states the following: [2235] bf probe 1 suction failure.Cause: the overflow sensor 1 s132 detected liquid after a washer 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 probable cause of the issue is attributed to a clogged bf wash probe.

Event Description

A customer reported receiving error 2235 bf probe 1 suction failure on the aia-900 analyzer.The customer indicated the probe tip was replaced, the probe cleaned and reseated, and the tubing intact and primed; however, the issue remained.An fse was notified.A field service engineer (fse) went onsite to address the reported issue, which resulted in the delay of reporting intact parathyroid hormone (ipth) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette o'connell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10443110
• MDR Text Key: 206364205
• Report Number: 8031673-2020-00233
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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