MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-07 for B BRAUN HEMODIALYSIS UNIT DIALOG + manufactured by B Braun.
[1414478]
In 2010, the biomedical medical technician discovered a problem with the b. Braun dialysis unit. He heard an unusual sound during the disinfection cycle. Upon investigation, he discovered one of the tubes in close proximity to the spinning fpa pump had nearly wore through the tubing. The biomedical technician contacted b. Braun and was told "we know about it" by one of their service. The biomedical technician replaced the tube, but shortened it to prevent it from touching the fpa pump to correct the situation. All dialysis units were checked. All 14 units had two loose mounting slotted screw at the motor mounting area which allowed the air assembly to turn. Pictures were taken of the unit and the affected tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014298 |
| MDR Report Key | 1577730 |
| Date Received | 2010-01-07 |
| Date of Report | 2010-01-07 |
| Date of Event | 2010-01-05 |
| Date Added to Maude | 2010-01-19 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B BRAUN HEMODIALYSIS UNIT |
| Generic Name | NONE |
| Product Code | FKP |
| Date Received | 2010-01-07 |
| Model Number | DIALOG + |
| Lot Number | BD13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B BRAUN |
| Manufacturer Address | 824 TWELFTH AVE BETHLEHEM PA 18018 US 18018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-01-07 |