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 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that the cell-dyn emerald power cord emitted sparks when plugged into the wall outlet.When the analyzer was powered on, it immediately powered off.There was no electric shock or injury caused by the power cord.Field service was dispatched to resolve the issue.

Manufacturer Narrative

The investigation included review of the complaint information, product historical data, and product labeling review.Per complaint information, return parts were not available because they were discarded due to waste liquid that soaked these parts.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.In this case, field service found liquid behind the unit caused by the waste line not being seated correctly.The ground fault interrupter (gfi) was tripped from liquid hitting the ac/dc power supply and caused sparks.Tripping of the gfi causes the power to immediately shut off to the outlet and any outlets along the circuit.Field service replaced the 70w switching power adapter because it got wet with waste material.The waste line was reseated to correct the waste leak and to prevent future occurrences.The cell-dyn emerald operator's manual states "place the ac adapter/transformer in a well-ventilated location at the rear of the instrument, away from any potential liquid spills." review of labeling concluded that the issue is sufficiently addressed.The incident was instrument-specific.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: 5487148
• MDR Text Key: 40131312
• Report Number: 2919069-2016-00014
• Device Sequence Number: 1
• Product Code: GKZ
• 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: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• 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: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2009
• 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