MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC STREAMLAB ANALYTICAL WORKCELL

Model Number STREAMLAB ANALYTICAL WORKCELL

Device Problems Smoking (1585); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

Smoke emission was detected from the streamlab core unit centrifuge assembly.The customer was unable to retrieve patient samples from the centrifuge.There was no report of injury to staff or impact to patients.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site for instrument and instrument data evaluation.The cse assisted the customer with replacing the centrifuge assembly.The cse aligned and configured the new centrifuge and aligned the robot.The cause of smoke being emitted from the centrifuge assembly was due to a centrifuge bucket failure.The replacement centrifuge assembly is performing within specifications.No further evaluation of the device is required.

Manufacturer Narrative

Siemens healthcare diagnostics has determined that centrifuge buckets for streamlab, aptio, and flexlab automation systems are failing prematurely.Urgent medical device correction (umdc) lai16-02.A.Us was sent to customers in the united states in may 2016 and corresponding urgent field safety notice (ufsn lai16-02.A.Ous) to all outside us customers.The umdc and ufsn are entitled "hettich centrifuge bucket model 4464-r" and provide customers with actions that can be taken by the customer to avoid potential centrifuge failures.

• Brand Name: STREAMLAB ANALYTICAL WORKCELL
• Type of Device: STREAMLAB ANALYTICAL WORKCELL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): INPECO S.P.A.; via givoletto 15; registration #: 3005509212; val della torre (torino), 10040 ; IT 10040
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4838719
• MDR Text Key: 5939653
• Report Number: 1226181-2015-00363
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/01/2016

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: STREAMLAB ANALYTICAL WORKCELL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 06/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1226181-05/24/2016-006-C
• Patient Sequence Number: 1