MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 08H67-03

Device Problem Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

The customer indicated that the cell-dyn ruby analyzer fan was not working.The field service engineer (fse) visited the customer site and observed that the top cover of the cell-dyn ruby analyzer was not the normal temperature.The fse opened the analyzer and upon inspection found that both fans were covered in soot.The fse replaced the fans.There was no report of any other damage or injury.

Manufacturer Narrative

(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The customer reported that the celldyn ruby fans were not functioning.The field service engineer (fse) found the presence of soot on both of the fans.The fans were replaced and instrument performance was verified.Inspection of the returned parts (fans) found discoloration of the magnetic coils of the fan and the presence of spider webs.In addition, a burn mark was observed on the pcb, and the center column of each fan was found to be off-center, indicating overheating; however the cause of the overheating could not be determined.Customer complaint data was reviewed and no adverse trends were identified.Trending data does not indicate other fans being off center.The cell-dyn ruby operations manual was reviewed and was found to adequately address the issue.The investigation did not identify a product deficiency.

• Brand Name: CELL-DYN RUBY ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 4218452
• MDR Text Key: 5070622
• Report Number: 2919069-2014-00070
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2014

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 Catalogue Number: 08H67-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 10/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1