MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2014L16-N manufactured by Pulsion Medical Systems Se.
[95625559]
Further information surrounding the event has been requested and investigation is ongoing. A supplemental medwatch report will be sent when the investigation is completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95625560]
During product investigation a crack has been detected in the luer connection of the catheter. No clinical consequences occurred. Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003263092-2017-00013 |
| MDR Report Key | 7135340 |
| Date Received | 2017-12-20 |
| Date of Report | 2018-03-28 |
| Date of Event | 2017-10-27 |
| Date Mfgr Received | 2017-12-04 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2017-12-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PULSION MEDICAL SYSTEMS SE HANS-RIEDL-STR. 21 |
| Manufacturer City | 85622 FELDKIRCHEN |
| Manufacturer Country | GM |
| Manufacturer Phone | 0498945991 |
| Manufacturer G1 | CHRISTINA KOEBERL |
| Manufacturer Street | PULSION MEDICAL SYSTEMS SE HANS-RIEDL-STR. 21 |
| Manufacturer City | 85622 FELDKIRCHEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PULSION PULSIOCATH THERMODILUTION CATHETERS |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2017-12-20 |
| Catalog Number | PV2014L16-N |
| Lot Number | 619480 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PULSION MEDICAL SYSTEMS SE |
| Manufacturer Address | PULSION MEDICAL SYSTEMS SE HANS-RIEDL-STR. 21 85622 FELDKIRCHEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-20 |