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

Model Number STREAMLAB ANALYTICAL WORKCELL

Device Problems Mechanical Problem (1384); Material Rupture (1546); Device Operational Issue (2914)

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

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.The cse replaced the centrifuge assembly, performed the alignments and pre-power checks.The cause of the centrifuge damage is unknown.

Event Description

The operator of a streamlab core unit centrifuge assembly stated that a centrifuge bucket failure occurred while the centrifuge was operating.The refrigeration coils were damaged and ruptured and the buckets were shattered but contained.There were 11 patient samples and one balance tube in the centrifuge during the failure and patient samples were damaged.There was no report of injury to operators or impact to patients.

Manufacturer Narrative

The initial mdr 1226181-2015-00447 was filed on july 31, 2015.Additional information (07/31/2015): a siemens customer service was re-dispatched to the customer site.The cse replaced the centrifuge module robot (cmr) bucket inserts and performed centrifuge module and cmr alignments.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.The actual manufacturer's address for the streamlab automation system has been corrected.

Manufacturer Narrative

The initial mdr 1226181-2015-00447 was filed on july 31, 2015.The first supplemental mdr 1226181-2015-00447_s1 was filed on july 31, 2015.The second supplemental mdr 1226181-2015-00447_s2 was filed on june 2, 2016.Additional information (05/27/2016): the customer filed a medwatch (mw5055270) with the fda.

• 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: 4957033
• MDR Text Key: 24645736
• Report Number: 1226181-2015-00447
• 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 faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 06/08/2016

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: Not provided
• Initial Date FDA Received: 07/31/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/02/2016; 06/08/2016
• 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