MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-31 for PERFUSOR? 8713030U manufactured by B. Braun Melsungen Ag.
| Report Number | 9610825-2020-00010 |
| MDR Report Key | 9654218 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-31 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2018-09-25 |
| Date Added to Maude | 2020-01-31 |
| 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 | MR. JONATHAN SEVERINO |
| Manufacturer Street | 861 MARCON BOULEVARD |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4842408332 |
| Manufacturer G1 | B. BRAUN MELSUNGEN AG |
| Manufacturer Street | CARL-BRAUN-STR. 1 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFUSOR? |
| Generic Name | PUMP, INFUSION, PCA |
| Product Code | MEA |
| Date Received | 2020-01-31 |
| Model Number | 8713030U |
| Catalog Number | 8713030U |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MELSUNGEN AG |
| Manufacturer Address | CARL-BRAUN-STR. 1 MELSUNGEN, 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |