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

Model Number 08H00-01

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

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 reported the cell dyn sapphire analyzer was providing error messages and behaving erratically.When they shut off the instrument there was a smell of burning.No visual smoke or fire occurred, but the damaged part showed signs of charring.There was no impact to user safety or patient management reported.

Manufacturer Narrative

The field service representative inspected the analyzer and replaced the pre-heater, the adcm, hcm and check valve.The defective part was the pre-heater (8921279803) which was found to have a connector that was short circuited, and the main body was bursting.The provided pictures were reviewed and it was concluded that the cable assembly connecting to the pre-heater assy (8921279803) appears to have been exposed to a liquid (possibly diluent) leaking from one of the sample cups or tubing directly above the pre-heater assy causing a short resulting in the burning smell.Review of product historical data for any trends and all customer complaints related to the issue did not identify any trends or abnormal complaint activity.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the cell-dyn sapphire analyzer was identified.

• 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
• MDR Report Key: 9979183
• MDR Text Key: 188271545
• Report Number: 2919069-2020-00012
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08H00-01
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/29/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1