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

Catalog Number 200100-US

Device Problem Data Problem (3196)

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

Event Date 01/16/2018

Event Type  malfunction  

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 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.

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 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
• Type of Device: WHOLE BLOOD HAEMOSTATIS SYSTEM
• Manufacturer (Section D): TEM INNOVATIONS GMBH; martin-kollar-strasse 13; 81829; munich, ; GM
• Manufacturer (Section G): TEM INNOVATIONS GMBH; martin-kollar-strasse 13; 81829; munich, ; GM
• Manufacturer Contact: thalia charles ; martin-kollar-strasse 13; 81829; munich, ; GM
• MDR Report Key: 7261133
• MDR Text Key: 100149644
• Report Number: 3005792925-2018-00001
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 04260160470020
• UDI-Public: 04260160470020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200100-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other