MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3700 CS ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 02H31-96

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

All available information was included.Additional details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed visible smoke on the cell-dyn cd3700 analyzer.There were no injuries.Service was called and the fan (pn115vac60htz) was cleaned (dust removed) and reconnected to the power supply, which appeared to resolve the issue.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The cause of the smoke was dust, no parts were replaced.The instrument was performing properly after reconnected connections of the power supply.As the dust accumulated inside the instrument may block the air flow coming out from the exhaust fan and failed to remove the heat dissipated from the instruments power supply or other components.As a result, the smoke may be coming from the burning dust due to the dissipated heat.Based on all available information and abbott diagnostics complaint investigation no product deficiency was identified.

• Brand Name: CELL-DYN 3700 CS ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 7879719
• MDR Text Key: 120388336
• Report Number: 2919069-2018-00045
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: K980614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2018

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 Catalogue Number: 02H31-96
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/16/2018
• Initial Date FDA Received: 09/16/2018
• Supplement Dates Manufacturer Received: 10/04/2018
• Supplement Dates FDA Received: 10/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1