MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH LEICA CM1860

Model Number 149491860US

Device Problems Fire (1245); Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 01/23/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a customer reported that while using an instant cooling agent (spray) on the freezing shelf in their cm1860 cryostat, the spray ignited causing combustion with fire to occur.This resulted in the user's face and eyebrows being burnt.Medical treatment was necessary.

Event Description

The affected instrument was inspected at the customer site by a leica biosystems regional technical specialist.The customer was advised that any flammable sprays shall not be used within the instrument.The investigation concluded that the potential cause was an applications issue due to the use of an unauthorized flammable spray.

• Brand Name: LEICA CM1860
• Type of Device: LEICA CM1860
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 8318778
• MDR Text Key: 135496742
• Report Number: 1423337-2019-00003
• Device Sequence Number: 1
• Product Code: IDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 149491860US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2019
• Distributor Facility Aware Date: 01/23/2019
• Event Location: Other
• Date Report to Manufacturer: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other