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

Model Number	DELTA
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Data review determined there was no malfunction of the instrument or barcode reader.The cause of the patient number ending changing from "y" to "z" was that the barcode reader was set to a (b)(4) keyboard layout.The barcode scanner was reconfigured to a (b)(4) keyboard layout, which resolved the issue.There was no patient impact, although there is potential for reporting the wrong results to a different patient therefore this incident report was submitted.No additional remedial action required.
Event or Problem Description
Customer reported an issue with their rotem delta.They scanned the barcode of a patient's id number which had a letter y at the end (eg.S1234567y) but the last letter for the id number that showed on the rotem delta was z (eg.S1234567z).There was no patient impact.

• Brand Name: ROTEM DELTA SYSTEM
• Common Device Name: WHOLE BLOOD HAEMOSTASIS SYSTEM
• Manufacturer (Section D): TEM INNOVATIONS GMBH; 13 martin-kollar-strasse; munich, gm 81829 ; GM 81829
• MDR Report Key: 7838638
• Report Number: 3005792925-2018-00005
• Device Sequence Number: 13750213
• Product Code: JPA
• UDI-Device Identifier: 04260160470020
• UDI-Public: 04260160470020
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K101533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DELTA
• Device Catalogue Number: 200100-US/JP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/31/2018
• 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