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 2020-02-14 for PERFUSOR? 8713030U manufactured by B. Braun Melsungen Ag.
[179485992]
(b)(4). Failure analysis and investigation results confirmed the reported issue. Upon receipt the actual pump involved was visually and inspected, and there was a shorted electronic component on the motherboard. The motherboard was replaced and the device was tested and met specifications. Although the evaluation determined that the reported issue was confirmed, no conclusions can be made regarding the cause of the reported event. If additional information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[179485993]
As reported by user facility: thermal damage was reported on a component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2020-00017 |
| MDR Report Key | 9713070 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2010-09-08 |
| Date Added to Maude | 2020-02-14 |
| 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 BLVD. |
| 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 | 2020-02-14 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 8713030U |
| Catalog Number | 8713030U |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-14 |