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

Catalog Number 08H00-01

Device Problem Use of Device Problem (1670)

Patient Problem Eye Injury (1845)

Event Date 04/02/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An operator was replacing the waste container on the cell-dyn sapphire when after disconnecting the tube, the cell-dyn sapphire started an automatic flush and splashed in her eyes.The operator was diagnosed with microburns and chemical keratitis with treatment of eye drops and intraocular antibiotic ointment.The operator was not wearing personal protective equipment.

Manufacturer Narrative

A review of the complaint information showed the instrument was in ready mode, and the customer stated that she replaced the waste container without waiting for the system initiated message (sim), "waste container full".Additionally, personal protective equipment (ppe) was not worn by the operator.A review of the product labeling concluded that the issue is sufficiently addressed; specifically, the cell-dyn sapphire operations manual under: principles of operation, under halt behavior associated with sims, hazards, under operator responsibility, hazards, under biological and chemical hazards, troubleshooting and diagnostics under 0425 waste full.A review of historical data, including complaint history review, service history review and tracking and trending showed no adverse trends or product issues.This event was determined to be due to use error.No product deficiency was identified for the cell-dyn sapphire.

• Brand Name: CELL-DYN SAPPHIRE ANALYZER
• 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: 5617376
• MDR Text Key: 43978062
• Report Number: 2919069-2016-00450
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2006
• 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