MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

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

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse was able to reproduce the issue and confirmed the issue by noting the waste was not being aspirated.The fse resolved the issue by rerouting the tubing which prevented it from crimping.System validation was completed through performing quality control (qc), using customer-prepared controls.Qc results passed within the published specifications.The aia-360 analyzer 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 10apr2018 to aware date 10may2019.There were no other similar complaints identified during the search period.The aia-360 operator's manual, chapter 7: error messages and flags, states the following: [2016] bf probe suction failure.Suction by the bf probe is abnormal.Contact the service department.The most probable cause of the reported event is attributed to the crimped waste tubing.

Event Description

A customer reported error message 2016 bf (bound-free) probe suction failure while operating on the aia-360 analyzer.The customer stated periodic maintenance (pm) was completed on the analyzer three days prior to the event.The aia-360 was not operable.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of beta-human chorionic gonadotropin (bhcg), estradiol (e2), and progesterone ii (prog ii) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 8656302
• MDR Text Key: 151506251
• Report Number: 8031673-2019-00187
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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