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 2017-11-20 for MARS 800147 manufactured by Baxter Healthcare - Rostock.
[93214946]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[93214947]
The customer stated that on a mars monitor, an internal leak (air) was noticed at the pin and pout luer lock adapters. It was not specified when in the process this occurred. 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
[115701246]
The device was serviced on-site by a qualified technician. Inspection of the device revealed that there was an internal leak of air in the pin and pout luer lock adapters. The cause of the condition was not determined. The pin and pout luer lock adapters were replaced to resolve this issue. A device history review revealed no issues during the manufacture of this device that could have caused or contributed to the issue. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the event. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007697864-2017-00067 |
| MDR Report Key | 7045009 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-20 |
| Date of Report | 2018-01-30 |
| Date of Event | 2017-10-23 |
| Date Mfgr Received | 2018-01-09 |
| Date Added to Maude | 2017-11-20 |
| 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 - 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 | 2017-11-20 |
| Model Number | NA |
| Catalog Number | 800147 |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - ROSTOCK |
| Manufacturer Address | ROSTOCK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-20 |