MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineering (fse) was at customer's site to resolve reported event.Fse confirmed the error and reproduced error after performing several prime bf washes.Fse replaced the wash syringe seal, the 2 way solenoid valve and the wash probe, but problem persisted intermittently.Fse was able to resolve the problem by replacing the waste pump of the bf washer #1.Analyzer was validated by running quality control (qc); qc run passed and within acceptable range.No further action required by field service.The aia-900 analyzer 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 no other similar complaints found during the searched period.The aia-900 operator's manual under section 12 flags and error messages states: 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 most probable cause of the reported event is due to faulty waste pump.

Event Description

A customer reported getting error message "2235 bf probe 1 suction failure" on the aia-900 analyzer.The customer replaced wash and diluent filters, primed wash and diluent, cleaned wash probes, and changed wash probe tips but error persisted.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of intact parathyroid hormone (ipth) patient results.There was no indication of patient intervention, or adverse health consequences due to the 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 oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9889901
• MDR Text Key: 222079050
• Report Number: 8031673-2020-00097
• 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
• Type of Report: Initial
• Report Date: 03/25/2020

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-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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