MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC STREAMLAB WORKCELL WITH CENTRIFUGE

Device Problems Overheating of Device (1437); Smoking (1585); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 01/23/2015

Event Type  Injury  

Event Description

Siemens streamlab centrifuge malfunctioned during operation approx 7am.Plastic tube specimens were thrown out of their locations within the buckets and broken.Centrifuge began to overheat, resulting in smoke.Lab was evacuated.Pt had to be redrawn.

• Brand Name: STREAMLAB WORKCELL WITH CENTRIFUGE
• Type of Device: STREAMLAB WORKCELL WITH CENTRIFUGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 1717 deerfield rd; deerfield IL 60015
• MDR Report Key: 4728349
• MDR Text Key: 5582090
• Report Number: MW5042262
• Device Sequence Number: 1
• Product Code: LXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2015

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: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention