MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS 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 01/22/2015

Event Type  malfunction  

Event Description

Smoke emission was detected from the streamlab core unit centrifuge assembly.The fire department was contacted, who checked the laboratory.There was no report of injury to staff, damage to property 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 determined the centrifuge assembly malfunctioned and required replacement.The cse installed a replacement centrifuge assembly and performed system alignments.The cause of smoke being emitted from the centrifuge assembly is unknown.The replacement centrifuge assembly is performing within specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 1226181-2015-00100 was filed on february 16, 2015.Additional information (06/12/2015): siemens healthcare diagnostics received a report that the customer filed with the fda's medwatch program for this event (mw5041975).The report states that patients needed to be redrawn.This information was not provided in the complaint made to siemens healthcare diagnostics for which the initial mdr was filed.

Manufacturer Narrative

The initial mdr 1226181-2015-00100 was filed february 16, 2015.The first supplemental mdr 1226181-2015-00100_s1 was filed on july 6, 2015.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; 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: 4519785
• MDR Text Key: 5446470
• Report Number: 1226181-2015-00100
• 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,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: 06/12/2015
• Initial Date FDA Received: 02/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/06/2015; 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