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

Catalog Number 02H31-01

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/12/2015

Event Type  Injury  

Event Description

An operator was performing maintenance and replacing the rbc metering tube assembly on the cell-dyn 3700 when cell-dyn diluent splashed into his eye from tubing that came loose from a solenoid valve which aspirates cell-dyn diluent.When performing maintenance, the operator was wearing protective eyewear and gloves while the instrument was off; however, when turning the instrument back on to verify the meniscus of the rbc metering tube, the operator had removed his protective eyewear.The tubing connected to solenoid valve 4-3 came loose, and the operator was splashed in the eye with diluent reagent.The operator's eye was washed, corticoid eye drops were given, and a patch covered the eye.The operator's eye recovered.No specific operator information was provided.

Manufacturer Narrative

(b)(4).The cell-dyn 3700 operator's manual hazards section provides precautionary warnings and information necessary for safe use of the cell-dyn 3700 system.Ticket tracking and trending was reviewed with no adverse trends noted.Based on the complaint information, the operator did not wear protective eyewear throughout the entire maintenance activity; therefore, this event is determined to be a use error.The cell-dyn 3700 analyzer is performing acceptably.

• Brand Name: CELL-DYN 3700 SL 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: 4662370
• MDR Text Key: 18657936
• Report Number: 2919069-2015-00016
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K980614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02H31-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention