MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-10 for FRESENIUS USA 03-7630-1 manufactured by Fresenius Usa.
[265754]
Found bend in arterial line when pt had been on tx 1hr 25min. Corrected bend. 10 minutes later pt became symptomatic with vomiting. Hypertension had been present also. System recirculated until physician order to restart was received. 0. 2mg clonidine po was given. Pt vomited again and physician ordered supplemental dose. Treatment discontinued early due to continued nausea/vomiting and cyanosis. Cyanosis became worse in spite of increased oxygen to 3 lnc. Vomiting continued. Pt sent to er per physician order.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 454968 |
| MDR Report Key | 454968 |
| Date Received | 2003-04-10 |
| Date of Report | 2003-04-04 |
| Date of Event | 2003-04-02 |
| Date Facility Aware | 2003-04-02 |
| Report Date | 2003-04-04 |
| Date Reported to Mfgr | 2003-04-04 |
| Date Added to Maude | 2003-04-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS USA |
| Generic Name | ARTERIAL BLOOD LINE |
| Product Code | FID |
| Date Received | 2003-04-10 |
| Model Number | 03-7630-1 |
| Catalog Number | 03-7630-1 |
| Lot Number | 1 LR 082 A |
| ID Number | * |
| Device Expiration Date | 2004-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 443965 |
| Manufacturer | FRESENIUS USA |
| Manufacturer Address | 95 HAYDEN AVE LEXINGTON MA 02420 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2003-04-10 |