MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC AUTOSTAINER LINK 48

Model Number AS480

Device Problem Misconnection (1399)

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

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: potential alteration of staining in this case was due to improper operation of the syringe (pn: 992641) and stopcock (pn: 992640).The problem was solved by field service engineer with repair of the parts.Following the repair, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following a syringe (pn: 992641) and stopcock (pn: 992640) malfunction or if the part stops working; the resulting failure modes could occur.Drip diluting reagents on slide, or probe leak altering aspiration/dispense.These failure modes have the potential to alter staining.

Event Description

Customer complaint record reported the event as follows, " instrument unable to dispense."no direct, indirect patient harm, or user harm have been reported.

• Brand Name: AUTOSTAINER LINK 48
• Type of Device: AUTOSTAINER LINK 48
• Manufacturer (Section D): DAKO NORTH AMERICA, INC; 6392 via real; carpinteria CA 93013
• Manufacturer (Section G): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria CA 93013
• Manufacturer Contact: sonia siddique ; 6392 via real; carpinteria, CA 93013 ; 5123328112
• MDR Report Key: 10714181
• MDR Text Key: 212381224
• Report Number: 2022180-2020-00361
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1