Model Number 01C-42640-06 |
Device Problem
Disconnection (1171)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/01/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is expected to be returned to the manufacturer for investigation.It has not been received.Investigation is not complete.
|
|
Event Description
|
The event involved a customer allegation regarding a transpac iv monitoring kit with safeset reservoir stating that during infusion, the pressure line was broken between the line and the blood withdrawal port.The device was replaced with no further problems encountered.There was patient involvement, however, there was no serious injury and no medical intervention required.The device was used with a philips monitor device and heparin saline medication.
|
|
Manufacturer Narrative
|
Received one (1) used partial set 01c-42640-06 transpac iv monitoring kit with safeset; reported lot# 3514084.As received, a tubing separation was observed between the 27" arterial pressure tubing and the safeset port.The reported complaint of tubing breakage or separation was confirmed.The cause of the separation was due to insufficient solvent.A dhr review for relevant commodities were completed and no non-conformance were found that could have contributed to the reported complaint.
|
|
Search Alerts/Recalls
|