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

Catalog Number 09H39-01

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that she had difficulty powering on the cell-dyn emerald analyzer on two different occasions.She reseated all components connected to the analyzer and reconnected the power cable into the wall outlet.She observed sparks coming from the back of the analyzer on (b)(6) 2017 when it was powered on.The exact location where the sparks originated could not be determined by the customer.The analyzer is connected to an uninterrupted power supply (ups).There was no smoke or fire observed and no injury occurred due to the sparks.

Manufacturer Narrative

Review of product historical data did not identify any adverse trends or abnormal complaint activity.A field service representative (fsr) inspected the instrument and did not find any obvious trace of the sparks.For precaution, the fsr replaced the cpu and the pre-amplifier boards.The boards shorted after being installed.The fsr noticed that while the instrument was running and the instrument was slightly turned, it would shutdown immediately.The 70w switching adapter and the boards were replaced.The replacements resolved the issue and the analyzer performed as expected.Repeated requests (more than 3 times) for the returned parts were unsuccessful.Due to the lack of returned parts, the definitive cause of the issue could not be verified.Labeling was reviewed and found to be adequate.Based on the available information, no product deficiency was identified.

• Brand Name: CELL-DYN EMERALD
• 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: 6842806
• MDR Text Key: 84992089
• Report Number: 2919069-2017-00130
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1