MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for 4IN SMALLBORE EXT SET WITH 1.2 MICRON FILTER B1755 manufactured by Icu Medical Inc.
[182332526]
Intralipids infusing using 1. 2 micron filter extension. Iv pump kept alarming occlusion, filter extension changed and lipids infused without alarm. Happened with 3 different patients, 2 saved packaged and have different lot numbers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9798145 |
| MDR Report Key | 9798145 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-25 |
| Report Date | 2020-01-27 |
| Date Reported to FDA | 2020-01-27 |
| Date Reported to Mfgr | 2020-03-06 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | 4IN SMALLBORE EXT SET WITH 1.2 MICRON FILTER |
| Generic Name | STOPCOCK, I.V. SET |
| Product Code | FMG |
| Date Received | 2020-03-06 |
| Catalog Number | B1755 |
| Lot Number | 3961763 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL INC |
| Manufacturer Address | 951 CALLE AMANECER SAN CLEMENTE CA 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |