MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) followed up with the site via telephone and was able to confirm the reported issue by having customer open the front panel of the analyzer.The fse was able to reproduce the reported complaint by having the customer run bf prime wash and customer reported that water was going into the wash pump area.Customer indicated that they looked at the waste container on the other aia-2000 analyzer and noticed that the analyzer with the leak was missing the o-ring.Customer stated that they found the o-ring that goes in the waste container and replaced the o-ring.Customer also stated that they ran several samples and the waste no longer leaked.Customer indicated that the issue is resolved and did not want on-site service.The aia-2000 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 the serial number: (b)(4) from (b)(6) 2019 through aware date of (b)(6) 2020.There were no similar complaints identified during the searched period.The most probable cause of the reported event was missing o-ring for the waste container.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

Customer reported that they are having a leak related to the waste tubing that goes into the waste bottle.Customer indicated that the waste tubing is leaking somewhere and is unable to see the source of the leak.Customer stated that the tubing is not blocked, twisted, or kinked to prevent proper flow.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting luteinizing hormone (lh ii), prolactin (prl), follicle stimulating hormone (fsh) and intact parathyroid hormone (ipth) 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-2000
• Type of Device: AIA-2000
• 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: 11126133
• MDR Text Key: 261057658
• Report Number: 8031673-2020-00387
• 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: 01/06/2021

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-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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