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 2017-11-06 for MARS 800541 manufactured by Baxter Healthcare - Rostock.
[92173291]
The unique device identifier for this device is (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[92173292]
During priming of an x-mars set, the customer noticed an external fluid leak. This occurred within a few minutes of starting prime during cycle 3. The x-mars set came apart at the connection between the dialyzer and the tubing. The tubing separated from the point where it should be bonded. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[115699260]
Correction: lot number. The device was received for evaluation. Visual inspection revealed that the line was detached from the hansen connector in unit 4. The reported condition was verified. The cause of the condition was determined to be an insufficient gluing of the hansen connector to the corresponding line during manufacture of the set. A nonconformance has been opened to address this issue. 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
| Report Number | 3007697864-2017-00062 |
| MDR Report Key | 7004866 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-06 |
| Date of Report | 2018-02-14 |
| Date of Event | 2017-10-12 |
| Date Facility Aware | 2017-10-13 |
| Report Date | 2017-11-06 |
| Date Reported to FDA | 2017-11-06 |
| Date Reported to Mfgr | 2017-11-06 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2017-11-06 |
| 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 - ROSTOCK |
| Manufacturer Street | FRIEDRICH-BARNEWITZ-STRASSE 4 |
| Manufacturer City | ROSTOCK 18119 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 18119 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARS |
| Generic Name | APPARATUS, HEMOPERFUSION, SORBENT |
| Product Code | FLD |
| Date Received | 2017-11-06 |
| Returned To Mfg | 2018-01-10 |
| Model Number | NA |
| Catalog Number | 800541 |
| Lot Number | 0000022811 |
| ID Number | NA |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - ROSTOCK |
| Manufacturer Address | ROSTOCK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-06 |