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 2019-12-11 for CLEARLINK BLOOD RECIPIENT SET FNC1173 manufactured by Baxter Healthcare Corporation.
[170435793]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[170435834]
It was reported that a? Piece of the tubing? Attached to the top of the filter chamber of a clearlink blood recipient set disconnected resulting in a loss of a portion of the blood this occurred during use on a patient in the general patient ward. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1416980-2019-06841 |
MDR Report Key | 9453727 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-12-11 |
Date of Report | 2020-02-25 |
Date of Event | 2019-10-21 |
Date Mfgr Received | 2020-02-10 |
Date Added to Maude | 2019-12-11 |
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 | BIOMEDICAL ENGINEER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
Manufacturer City | ROUND LAKE IL 60073 |
Manufacturer Country | US |
Manufacturer Postal | 60073 |
Manufacturer Phone | 2242702068 |
Manufacturer G1 | BAXTER HEALTHCARE - SINGAPORE |
Manufacturer Street | 2 WOODLANDS INDUSTRIAL PARK D |
Manufacturer City | SINGAPORE 738750 |
Manufacturer Country | SN |
Manufacturer Postal Code | 738750 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CLEARLINK BLOOD RECIPIENT SET |
Generic Name | SET, BLOOD TRANSFUSION |
Product Code | BRZ |
Date Received | 2019-12-11 |
Model Number | NA |
Catalog Number | FNC1173 |
Lot Number | NI |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BAXTER HEALTHCARE CORPORATION |
Manufacturer Address | DEERFIELD IL |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-12-11 |