MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for UF FILTER UNK manufactured by Unknown.
[124978806]
The uf filter head for the ro loop plumbed for central bicarbonate system was molded incorrectly, so there was no flow to the inlet side of the housing head. An additional uf filter plumbed in parallel with the defective device prevented immediate recognition of device failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7995181 |
| MDR Report Key | 7995181 |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-09-25 |
| Date Facility Aware | 2018-09-25 |
| Report Date | 2018-10-11 |
| Date Added to Maude | 2018-10-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UF FILTER |
| Generic Name | UF HOUSING HEADER CAP |
| Product Code | JRS |
| Date Received | 2018-10-11 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-11 |