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

Catalog Number	02H31-03
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in process.
Event or Problem Description
The customer observed visible smoke and experienced an electrical failure of the cell-dyn 3700sl analyzer.The customer disconnected the equipment from the electrical current and no exterior damage was observed.No injuries or fire were reported.
Additional Manufacturer Narrative
The customer returned the cell-dyn 3700 analyzer for investigation.Evaluation of the customer issue included a complaint text review, a search for similar complaints, analysis of the returned analyzer, instrument service review, and labeling review.Historical complaint data was reviewed.No adverse trend or systematic issue was identified for the smoke/burn issue identified in the complaint.Analysis of the returned analyzer showed the smoke was most likely coming from the power supply module exhaust fan on the back of the analyzer.The smoke was the result of a worn printed circuit board (pcb) assy, power supply (ps) (dc) [part 9601180].This part was considered the likely cause of the smoke issue.The burnt traces on the pcb assy, ps (dc) were not caused by any solenoid valves being overloaded with current.All the solenoid valves were checked and confirmed with nominal dc resistance of 70 ohms.The damage was contained within the analyzer, and the customer stated that no external damage to the user facility occurred.This cell-dyn 3700 analyzer was refurbished (march 2010) and became serial number (sn) (b)(4).The serial number prior to the refurbishment was sn (b)(4).The analyzer was manufactured in july 2003.Service history showed the pcb assy, ps (dc) that was considered the likely cause part was the original board in the analyzer since the instrument was first placed in service (installed) in august 2003.The analyzer service history was reviewed and no contributing factors for the smoke/burn issue were found.Product labeling was reviewed and found to be adequate, as it contains instructions regarding electrical specifications and requirements, electrical hazards, and of electrical safety for the cell-dyn systems.The cell-dyn 3700 analyzer ul certification was reviewed.The system is ul61010a-1 certified and complies with safety standards.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: CELL-DYN 3700 SL ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY AN
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 7336246
• Report Number: 2919069-2018-00019
• Device Sequence Number: 16164392
• Product Code: GKZ
• UDI-Device Identifier: 00380740002732
• UDI-Public: 00380740002732
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K980614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 02H31-03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1