MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-25 for PULSION PICCO MONITORING KIT PV8115 manufactured by Pulsion Medical Systems Se.
[139967510]
Further information has been requested. The involved product was returned for investigation 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
[139967511]
It was reported that a leakage was found at the male luer-lock of the monitoring kit after 4 hours of use. No harm to the patient occurred. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003263092-2019-00003 |
| MDR Report Key | 8448240 |
| Date Received | 2019-03-25 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2019-03-25 |
| 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 | 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 PICCO MONITORING KIT |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2019-03-25 |
| Returned To Mfg | 2019-03-21 |
| Catalog Number | PV8115 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PULSION MEDICAL SYSTEMS SE |
| Manufacturer Address | HANS-RIEDL-STRASSE 17 FELDKIRCHEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-25 |