MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN SMS; AUTOMATED BLOOD FILM PREPARATION AND STAINING

Catalog Number 05H29-04

Device Problem Sparking (2595)

Patient Problem No Code Available (3191)

Event Date 10/23/2018

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 saw sparking on the left back part of the cell-dyn sms (slide maker stainer) system and observed error message, pressure pump failed.The customer stated no smoke or fire (flame) was seen and no exposure or personal injury occurred.

Manufacturer Narrative

An abbott field service engineer was dispatched to the account and found the pressure pump fuse was blown [fuse fast 1a 250v 5x20mm part 8510020801].The sparking from the equipment was limited to this part and did not spread to other parts of the equipment.After the fuse was replaced, the analyzer was returned to normal operation.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling.The replaced fuse is intended to protect the pressure pump from excessive current and performed as intended.No returns were made available from the customer site for this evaluation.No subsequent reports of sparking issues were identified.No adverse trend or systematic issue was identified for the issue identified in the complaint.Product labeling was reviewed and found to be adequate, as it contains instructions regarding electrical specifications and requirements, electrical hazards, and of electrical safety for the cell-dyn sms system operator's manual.The issue was resolved through normal service procedures.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified, and no product deficiency was found.

• Brand Name: CELL-DYN SMS
• Type of Device: AUTOMATED BLOOD FILM PREPARATION AND STAINING
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 8081995
• MDR Text Key: 128270444
• Report Number: 2919069-2018-00056
• Device Sequence Number: 1
• Product Code: GKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05H29-04
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1