MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for AQURE SYSTEM 933-599 manufactured by Radiometer Medical Aps.
[146361997]
When using the third party device haemonetics teg together with aqure and his/lis, incorrect patient data was sent by aqure to haemonetics teg manager thus causing patient data mix-up. The incorrect data may be transmitted to aqure and his/lis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2019-00015 |
| MDR Report Key | 8548636 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-07-15 |
| Device Manufacturer Date | 2018-06-29 |
| Date Added to Maude | 2019-04-25 |
| 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 | MR. TOM ENGDAHL |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3002807968-07/15/19-002C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AQURE SYSTEM |
| Generic Name | AQURE SYSTEM |
| Product Code | OUG |
| Date Received | 2019-04-25 |
| Model Number | 933-599 |
| Catalog Number | 933-599 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AAKANDEVEJ 21 BROENSHOEJ, 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |