MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Computer Operating System Problem (2898)

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

Event Date 04/18/2014

Event Type  malfunction  

Event Description

The operator of a centralink data management system observed sample tubes circling around a track without being processed.A siemens headquarters support center (hsc) specialist evaluated the log files and determined that the "dispatch to las" and "upload validated results" tasks had stopped.There are no reports of adverse health consequences due to tasks stopping on the centralink data management system.

Manufacturer Narrative

Siemens healthcare diagnostics has investigated this issue and identified a task scheduler issue with the centralink¿ data management system, software version 14.The issue may cause the software to stop executing commands, including uploading validated results to the lis.The issue is related to an internal software timer that overflows after 24 days.Automated rules triggered by task schedulers or by actions in the centralink user interface may also be affected.As each customer configuration is unique, in addition to the delay in uploading of validated results, the specific consequences of discontinued command execution will vary.Urgent medical device correction (umdc) 10819364 entitled "centralink data management system task scheduler issue" was sent to customers in the united states and urgent field safety notice (ufsn) 10819365 entitled "centralink data management system task scheduler issue" was sent to customers outside of the united states in august 2014.The umdc and ufsn describes the issue and provides guidance on how to prevent the issue from occurring.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; chapel lane; registration number: 8020888; dublin, swords, co. ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4064793
• MDR Text Key: 20755951
• Report Number: 2432235-2014-00529
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/12/2014

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: CENTRALINK DATA MANAGEMENT SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 09/05/2014
• 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: 2432235-08/25/2014-001-C
• Patient Sequence Number: 1