FDA Adverse Event
Malfunction
Summary report: N
PULSIOCATH PICCO MONITORING KIT
MDR report key: 4973765
·
Received July 22, 2015
Report
- Report Number
- 3003263092-2015-00002
- Event Type
- Malfunction
- Date Received
- July 22, 2015
- Date of Event
- May 16, 2015
- Report Date
- January 23, 2020
- Manufacturer
- PULSION MEDICAL SYSTEMS SE
- Product Code
- KRB
- PMA / PMN Number
- K020587
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO REC'D INFO THE DEVICE WAS DISCARDED BY THE USER & IS NOT AVAILABLE FOR INVESTIGATION. FURTHER INFO SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER ONE HOUR OF USING A PICCO MONITORING KIT ON A PATIENT, A STERILE FLUIDS LOSS AND AN ARTERIAL BLOOD RETURN IN THE PRESSURE LINE AND ON THE GROUND WERE OBSERVED. TWO TUBING CONNECTORS OF THE PRESSURE TRANSDUCER WERE FOUND LOOSE. THE LOOSE CONNECTORS WERE TIGHTENED BUT A NEW LOOSE CONNECTION WAS NOTICED DURING SAMPLING. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474145 | PULSIOCATH PICCO MONITORING KIT | PROBE, THERMODILUTION | KRB | PULSION MEDICAL SYSTEMS SE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |