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

Model Number DELTA

Device Problem Installation-Related Problem (2965)

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

Event Date 08/08/2018

Event Type  Injury  

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 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
• Type of Device: WHOLE BLOOD HAEMOSTASIS SYSTEM
• Manufacturer (Section D): TEM INNOVATIONS GMBH; 13 martin-kollar-strasse; munich, gm 81829 ; GM 81829
• Manufacturer (Section G): TEM INNOVATIONS GMBH; 13 martin-kollar-strasse; munich, gm 81829 ; GM 81829
• Manufacturer Contact: reba daoust ; 13 martin-kollar-strasse; munich, gm 81829 ; GM 81829
• MDR Report Key: 7838638
• MDR Text Key: 118945364
• Report Number: 3005792925-2018-00005
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 04260160470020
• UDI-Public: 04260160470020
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K101533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DELTA
• Device Catalogue Number: 200100-US/JP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other