MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-13 for EFFLUENT BAG 107650 manufactured by Baxter Healthcare Corporation.
[179330198]
(b)(6). Twenty six samples were returned for evaluation. Visual analysis by the naked eye was performed, and it was noted that the solvent between the tube and the bag was not present on the entirety of the tube. During manipulation, a tube of one of the samples became disconnected from the bag. The samples underwent an underwater leak test whilst attached to a provaset. Fourteen of the returned samples leaked whilst eleven did not leak. The reported leak was confirmed on fourteen samples, one sample was confirmed for disconnection and eleven samples were not confirmed. Should additional relevant information become available, a supplemental report will be submitted. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[179330199]
It was reported during a patient? S treatment, an external fluid leak from four 9l effluent drain bags was observed around the drain valve. The bags were replaced. It was reported that no alarm was triggered. 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 | 1416980-2020-00657 |
| MDR Report Key | 9708189 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-07-16 |
| Date Added to Maude | 2020-02-13 |
| 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 - MALTA |
| Manufacturer Street | A47 INDUSTRIAL ESTATE |
| Manufacturer City | MARSA |
| Manufacturer Country | MT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EFFLUENT BAG |
| Generic Name | SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES |
| Product Code | MON |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-29 |
| Model Number | NA |
| Catalog Number | 107650 |
| Lot Number | 19F10V828 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-13 |