MAUDE Adverse Event Report: TEM INNOVATIONS GMBH ROTEM DELTA SYSTEM; WHOLE BLOOD HAEMOSTATIS SYSTEM

Catalog Number	200100-US
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Company technical support visited the site and was unable to replicate the issue.This incident is currently under investigation and a follow-up report will be filed.
Event or Problem Description
Customer reported that the rotem merged the demographic from one patient with the result of another patient on the report.The patient results were not used for treatment and no patient harm was reported.
Additional Manufacturer Narrative
A capa was initiated as part of the investigation.Root cause is a defect in the software that allows a click by a user within a certain time window to alter the association of patient data from one sample to another.A new software was released, and confirmed with correction of the defect.New software changes the way data is presented by using a pdf viewer.This method prevents the actions from the user (inadvertent clicks) from altering the information presented and the association of that information within the record.The next step of the capa is reviewing complaints at the of july and ensuring that has not been a recurrence of the defect.
Event or Problem Description
Customer reported that the rotem merged the demographic from one patient with the result of another patient on the report.The patient results were not used for treatment and no patient harm was reported.

• Brand Name: ROTEM DELTA SYSTEM
• Common Device Name: WHOLE BLOOD HAEMOSTATIS SYSTEM
• Manufacturer (Section D): TEM INNOVATIONS GMBH; martin-kollar-strasse 13; 81829; munich, ; GM
• MDR Report Key: 7261133
• Report Number: 3005792925-2018-00001
• Device Sequence Number: 19289471
• Product Code: JPA
• UDI-Device Identifier: 04260160470020
• UDI-Public: 04260160470020
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 200100-US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other