MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012)

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

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched (b)(6) 2017.The fse was able verify and reproduce the error 101 low pressure after a startup from cold boot letting the system prime on initialization.The fse repeated process and saw error re-occur.The fse replaced the buffer valve #1 (found slight nick in the valve cable) and manually primed and performed drain flush.The fse also replaced buffer #3 and primed and observed individual buffer valve pressure to column head by manually switching to each valve with no pressure drops.The fse cold booted the system and allowed full initialization to standby through boot up software initialization.No re-occurence of error 101 on start from zero pressure (standby).No re-occurence on cold boot initialization.No low pressure when manually switching buffer valves with flow on.The fse ran controls and got identical results with two runs and ran recision on 10 new patient samples.The fse also observed 3 rack patients; the run was successfull.No further action required by fse.The g8 analyzer was functioning as intended with all issues cleared.The most probable cause of the reported event was pump unit fault of high pressure pump system.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).

Event Description

On (b)(6) 2017 a customer reported low pressure with the g8 analyzer.The customer is unable to run hbaic patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hbaic patient results.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: TOSOH HLC-723G8 ANALYZER G8
• 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 (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7339525
• MDR Text Key: 102596499
• Report Number: 8031673-2018-01876
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/14/2018

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: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2018
• Distributor Facility Aware Date: 01/24/2017
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/14/2018
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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