MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. AUTOSTAINER LINK 48

Model Number AS480

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: potential alteration of staining in this case was due to improper operation of the dispense check valve (3 psi one way valve).The problem was solved by field service engineer with replacement of the part.Following the replacement, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following a dispense check valve malfunction or if the part stops working; the resulting failure mode could occur.Small leak could result in drops of buffer from the probe after wash or dispensing aberration resulting in low volume dispensed (first dispense).This failure mode has the potential to alter staining.

Event Description

Based on complaint report or investigated failure mode, there was potential for a staining alteration.Customer complaint record reported the event as follows: tip leaks while pumping liquid.No direct or indirect patient harm or user harm have been reported.

Event Description

Based on complaint report or investigated failure mode, there was potential for a staining alteration.Customer complaint record reported the event as follows: tip leaks while pumping liquid no direct or indirect patient harm or user harm have been reported.

• Brand Name: AUTOSTAINER LINK 48
• Type of Device: AUTOSTAINER LINK 48
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, 76892 3; SN 768923
• MDR Report Key: 11059864
• MDR Text Key: 228018690
• Report Number: 3003423869-2020-00002
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700572035497
• UDI-Public: 05700572035497
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AS480
• Device Catalogue Number: AS48030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1