MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2011-06-22 for BM14 FLUID UF MODULE FOR BM25 5M3052FR manufactured by Edwards Lifesciences Germany Gmbh.
[2017450]
A customer reported to baxter that after initial start up of the bm25, the bm14 shut off after 30 sec. The instrument could not be used for the patient treatment. No patient involvement. The instrument will be returned for investigation/repair.
Patient Sequence No: 1, Text Type: D, B5
[9155839]
(b)(4). This international product is distributed outside the u. S. And does not have a 510k number, but it is being reported as it is the same or similar to a product distributed within the u. S. The actual instrument was received, evaluated and repaired. The root cause was the power supply board (230 volts). Transportation caused several condensers and diodes to loosen, resulting in voltage fluctuations and sparking. Thus, it was not possible to establish correct communication with bm14. This, in turn, caused the bm14 to switch off again, since it is controlled via the bm11.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2011-08137 |
| MDR Report Key | 2136889 |
| Report Source | 01,04 |
| Date Received | 2011-06-22 |
| Date of Report | 2011-02-11 |
| Date of Event | 2011-01-27 |
| Date Mfgr Received | 2011-05-30 |
| Date Added to Maude | 2011-12-01 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VIRGINIA MCKINNEY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472702835 |
| Manufacturer G1 | EDWARDS LIFESCIENCES GERMANY GMBH |
| Manufacturer Street | EDISONSTRASSE 3-4 |
| Manufacturer City | UNTERSCHLEISSHEIM D85716 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D85716 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BM14 FLUID UF MODULE FOR BM25 |
| Generic Name | PUMP, BLOOD, EXTRA-LUMINAL |
| Product Code | FIR |
| Date Received | 2011-06-22 |
| Catalog Number | 5M3052FR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES GERMANY GMBH |
| Manufacturer Address | D85716 GM D85716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-22 |