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 2017-11-07 for MARS DISPOSABLE 800473 manufactured by Baxter Healthcare - Rostock.
[92215096]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[92215097]
During priming of a mars kit, the customer noticed an external fluid leak. The mars kit leaked fluid at the connection between the waste bag and the line. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[115704166]
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The actual sample was received and evaluated. The evaluation confirmed that there is a leakage at the waste bag. The reported condition was verified. The cause of the condition was determined to be a supplier manufacturing issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007697864-2017-00064 |
| MDR Report Key | 7005803 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-07 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-10-13 |
| Date Mfgr Received | 2017-12-15 |
| Date Added to Maude | 2017-11-07 |
| 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 DISPOSABLE |
| Generic Name | APPARATUS, HEMOPERFUSION, SORBENT |
| Product Code | FLD |
| Date Received | 2017-11-07 |
| Returned To Mfg | 2017-10-27 |
| Model Number | NA |
| Catalog Number | 800473 |
| Lot Number | 0000022360 |
| ID Number | NA |
| 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 | 2017-11-07 |