MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-02 for FRESENIUS 2008T manufactured by Fresenius Medical Care.
[4271236]
Venous needle came out of patient's arm. Patient loss greater than 100cc of blood. Patient became unresponsive with no pulse noted. Patient given normal saline through arterial needle. Cpr initiated. Patient arousable with pulse upon transfer to hospital per (b)(6) ambulance. Needle was noted to have 1 piece of tape left on it. Patient returned to clinic on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3731300 |
| MDR Report Key | 3731300 |
| Date Received | 2014-04-02 |
| Date of Report | 2014-02-12 |
| Date of Event | 2014-02-03 |
| Date Facility Aware | 2014-02-03 |
| Report Date | 2014-02-12 |
| Date Reported to Mfgr | 2014-02-13 |
| Date Added to Maude | 2014-04-08 |
| 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 | 3 |
| 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 2008T |
| Generic Name | 2008T |
| Product Code | FKP |
| Date Received | 2014-04-02 |
| Model Number | 2008T |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE |
| Manufacturer Address | WALTHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-04-02 |