MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-08-31 for ROTEM DELTA SYSTEM 200100-US/JP manufactured by Tem Innovations Gmbh.
[118945364]
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.
Patient Sequence No: 1, Text Type: N, H10
[118945365]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005792925-2018-00005 |
| MDR Report Key | 7838638 |
| Report Source | FOREIGN |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-08-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS REBA DAOUST |
| Manufacturer Street | 13 MARTIN-KOLLAR-STRASSE |
| Manufacturer City | MUNICH, GM 81829 |
| Manufacturer Country | GM |
| Manufacturer Postal | 81829 |
| Manufacturer G1 | TEM INNOVATIONS GMBH |
| Manufacturer Street | 13 MARTIN-KOLLAR-STRASSE |
| Manufacturer City | MUNICH, GM 81829 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 81829 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTEM DELTA SYSTEM |
| Generic Name | WHOLE BLOOD HAEMOSTASIS SYSTEM |
| Product Code | JPA |
| Date Received | 2018-08-31 |
| Model Number | DELTA |
| Catalog Number | 200100-US/JP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEM INNOVATIONS GMBH |
| Manufacturer Address | 13 MARTIN-KOLLAR-STRASSE MUNICH, GM 81829 GM 81829 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-31 |