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

Catalog Number 09H39-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Aspiration/Inhalation (1725)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that when the field service engineer performed a bleach maintenance on the cell dyn emerald she was present and suffered an asthma attack.The customer suffers from asthma and has an allergy to bleach.Due to the exposure to the bleach fumes she had to take an emergency asthma treatment /medication (dounab inhaler, allavert, predozone, and singulair).The treatment was successful in halting the asthma attack and no further treatment was necessary.

Manufacturer Narrative

This investigation was performed for the bleach exposure causing an asthma attack.The parts, electrovalve 2-2, and optical probe sensor, were replaced by field service to resolve the customer's reported issue and why service was at the site.A review of product historical data did not identify any trends or additional customer complaints for this issue.A review of the cell-dyn emerald operator's manual provides adequate information to address this incident.Per the information within the complaint record, the device met performance specifications and performed as intended at the customer site.Based on this investigation no product deficiency was identified for the cell-dyn emerald, list number 09h39-01, serial number (b)(4).

• 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: 7029163
• MDR Text Key: 91945105
• Report Number: 2919069-2017-00156
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2010
• 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
• Patient Outcome(s): Required Intervention