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

Model Number 08H00-01

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer reported an error related to the wbc dilution cup temperature on the cell dyn sapphire analyzer.When the abbott tss arrived on site, he smelled a burning smell.There was no visible fire or smoke observed.During the site visit the tss found a charred component due to leaking.There was no impact to patient management, user safety, or facility damage reported.

Manufacturer Narrative

During the requested site visit, the field service representative (fsr) noticed a burning smell and the instrument was powered off.After inspecting the analyzer, leaking and a circuit board with burned circuits were found, but no fire or visible smoke was observed.The fsr replaced the 8921279803 assy, pre-htr cdsphr, rohs, and 8932075802 sample cup, rear, which resolved the issue.Instrument operation was confirmed to be within specification after the replacements were made.An analysis of the failed part determined that the short circuit was caused by build-up of liquid and salts coming from the leak dripping from the rbc cup (8932075802 sample cup, rear) onto the electronics (8921279803, assy, pre-htr cdsphr, rohs), causing the electronics to short circuit, resulting in the pre-heater and attached cable components to fail.Returns were not necessary for the investigation.A 12-month review for the assy, pre-htr cdsphr, rohs (part number 88921279803) and the sample cup, rear (part number 8932075802) did not identify any trends for the parts regarding the current complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for either the assy, pre-htr cdsphr, rohs (part number 88921279803) or the sample cup, rear (part number 8932075802).

• 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: 9512452
• MDR Text Key: 190384134
• Report Number: 2919069-2019-00118
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1