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 2018-07-24 for MARS 800540 manufactured by Baxter Healthcare - Rostock.
[114945055]
(b)(6). Recall:correction/removal report number: 3007697864-12/12/2017-001-r. 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. A visual inspection was performed on the returned samples. The detached hansen connector was clearly visible and was caused by an insufficient gluing of the connector to the line. The reported condition was verified. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[114945056]
It was reported that during set up of a mars kit gambro set, it was observed that there was a missing screw and an unspecified missing component in the tubing. During priming of the line, the pressure resulted in the disconnection of the hansen connector between the screw and the tube, causing the blood system to be opened. There was the presence of air inside the tubing. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007697864-2018-00006 |
| MDR Report Key | 7715611 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-24 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-06-29 |
| Date Added to Maude | 2018-07-24 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARS |
| Generic Name | APPARATUS, HEMOPERFUSION, SORBENT |
| Product Code | FLD |
| Date Received | 2018-07-24 |
| Returned To Mfg | 2018-07-04 |
| Model Number | NA |
| Catalog Number | 800540 |
| Lot Number | 0000022803 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-07-24 |