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 2017-10-22 for MARS 800540 manufactured by Baxter Healthcare - Rostock.
[90699395]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[90699396]
During priming of prismaflex device, the machine alarmed prime self-test (code 20) - malfunction alarm. After correction of this error, a leak from the filter connection port from the mars disposable was detected. Following this, a disconnection of the tubing from the connection port was observed. The set could not be used. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[115700046]
Correction: lot number. . A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was received for evaluation. Visual inspection of the returned sample showed that the line was detached from the hansen connector in unit 4. The detached hansen connector was clearly visible and caused by an insufficient gluing of the connector to the line. The reported condition was verified. The cause of the condition was determined to be a manufacturing issue. A nonconformance has been opened to address this issue. Furthermore, it was detected that the luer lock connectors at the lower part of cartridge diamars ie and cartridge diamars ac were broken. The cause of the broken connectors at the upper side of the cartridges was determined to be rough handling during deinstallation of the treatment kit. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007697864-2017-00059 |
| MDR Report Key | 6967848 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-22 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-09-16 |
| Date Mfgr Received | 2017-11-27 |
| Date Added to Maude | 2017-10-22 |
| 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 | 2017-10-22 |
| Returned To Mfg | 2017-10-09 |
| Model Number | NA |
| Catalog Number | 800540 |
| Lot Number | 0000022760 |
| 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 | 2017-10-22 |