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 2018-03-09 for MARS 800540 manufactured by Baxter Healthcare - Rostock.
[102089613]
The lot number of the prismaflex set (part of the mars kit) is 15k1701. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[102089614]
It was noticed during liver support therapy using a mars kit gambro type 1116/1 that two tubes of the prismaflex mars set were inverted. The effluent output line was glued to the inlet pbp pump and the inlet pbp line was glued to the output effluent pump. The incorrect assembly of the lines was observed after approximately 15-20 minutes and treatment was terminated with blood return. Mars treatment was not restarted using a new set (reason not provided). Per the customer, the patient did not present with any weight imbalance, e. G. Hypo- or hypervolemia, in connection with the reported event. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[115699445]
Lot number? A potentially associated lot number (0000022017) was identified. The actual device was not available; however, a photograph of the sample was provided for evaluation. The visual inspection showed that the pbp and effluent lines are incorrectly assembled on the support plate. The reported condition was verified. The cause of the condition is due to human error during the manufacturing process. A batch review was conducted for the potentially associated lot number 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 | 3007697864-2018-00004 |
| MDR Report Key | 7327714 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-09 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-02-12 |
| Date Mfgr Received | 2018-03-20 |
| Date Added to Maude | 2018-03-09 |
| 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 | 2018-03-09 |
| Model Number | NA |
| Catalog Number | 800540 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-03-09 |