Device product
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.
Z-1121-2015
Product summary
- Event
- Event 69782
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 units
- Official record key
device-enforcement:Z-1121-2015
Official wording
Reason: Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
Code information: Model Number PV8810US; Lot # 14AK20 and 14EK20
Distribution pattern: US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
Derived failure modes
-
Unknown
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging