MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Suction Failure (4039)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the error 2016 suction failure by viewing the error log.The fse was unable to reproduce the error 2016 suction error but did find the metal suction tube on the wash probe to be loose.The fse replaced the wash probe.Customer's quality control (qc) was already diluted when they received it so no pipetting was needed.The instrument was returned to operational status.The aia-360 analyzer performed as intended and returned to operation.No further action required by field service.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 29aug2019 through aware date (b)(6) 2020.There were no similar complaints identified during the search period.The aia-360 operator's manual under chapter 7- list of error messages states the following: [2016] error message: bfprobe suction failure.Description: suction by the bf probe is abnormal.Troubleshooting: contact the service department.The most probable cause of the reported event was that the wash probe metal suction tube was loose.

Event Description

Customer called to report an error 2016, bf probe suction failure on the aia-360 analyzer.Customer states this has been going on for about 3 weeks.Customer states this happens everyday.Customer primes and the instrument recovers.Customer was contacted by a doctor questioning a less than low result, so she re-ran and it was much higher.The technical support specialist (tss) advised customer to stop running the analyzer.The field service engineer (fse) was dispatched.

• Brand Name: AIA-360
• Type of Device: AIA-360
• 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: 11066133
• MDR Text Key: 230000159
• Report Number: 8031673-2020-00381
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2020
• 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