MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-12 for APEX? AX1000 manufactured by B. Braun Medical Inc.
[187073049]
This report has been identified as b. Braun medical inc. Internal report number (b)(4). The investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
Patient Sequence No: 1, Text Type: N, H10
[187073050]
As per b. Braun implementation specialist: customer reported while compounding an order the pharmacist noticed mvi dispensing out of sequence. Mvi was located on port 19 and should have dispensed fourth in the sequence. The pump was immediately shut down and the bag was scrapped. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1641965-2020-00004 |
| MDR Report Key | 9699250 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2020-01-25 |
| Date Added to Maude | 2020-02-12 |
| 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 | 4847197287 |
| Manufacturer G1 | B. BRAUN MEDICAL INC |
| Manufacturer Street | 1601 WALLACE DRIVE, SUITE 150 |
| Manufacturer City | CARROLLTON TX 750066690 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 750066690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APEX? |
| Generic Name | COMPOUNDER |
| Product Code | NEP |
| Date Received | 2020-02-12 |
| Model Number | AX1000 |
| Catalog Number | AX1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC |
| Manufacturer Address | 1601 WALLACE DRIVE, SUITE 150 CARROLLTON TX 750066690 US 750066690 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |