MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-02-20 for INTERLINK MICRO-VOLUME EXTENSION SET 1C8740 manufactured by Baxter Healthcare Corporation.
[180316113]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[180316115]
It was reported that an unspecified quantity of interlink system non-dehp minivolume extension sets were leaking from a hole in the filter. The leaks were observed a few hours later after the patient was connected for therapy. This issue was not observed during priming. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[188636435]
Additional information was added: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2020-00850 |
| MDR Report Key | 9734964 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-20 |
| 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 | 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 CORPORATION |
| Manufacturer Street | NI NI |
| Manufacturer City | NI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERLINK MICRO-VOLUME EXTENSION SET |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2020-02-20 |
| Model Number | NA |
| Catalog Number | 1C8740 |
| Lot Number | ASKU |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |