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.
[95640937]
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
[95640938]
A crack in the luer connection of the catheter has been reported. No clinical consequences occurred. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[120315798]
Only one out of five complained products was returned for investigation (see mdr 3003263092-2017-00013). The crack could be confirmed for the returned product. A review of the dhr could not identify any non-conformities or deviations relevant to the reported issue. The same issue appeared in the same hospital five times within three days (see mdr 3003263092-2017-00009, -00010, -00011, and 00013). In all five cases not only the catheter luer lock but also the hub of the needle showed a crack. On the basis of the issue description, as well as on investigation result and experience, it is considered as unlikely that a production error is the root cause. This is supported by the fact that no similar events were reported throughout 2017. The real root cause could not be determined. It is considered as likely that a handling error during use or external force applied by the user have contributed to the events. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[120315799]
Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003263092-2017-00012 |
| MDR Report Key | 7135287 |
| Date Received | 2017-12-20 |
| Date of Report | 2018-03-28 |
| Date of Event | 2017-10-27 |
| Date Mfgr Received | 2017-12-06 |
| 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 | N |
| Device Age | YR |
| Device Eval'ed by Mfgr | * |
| 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 |