|
Lot Number 4108674 |
Device Problems
Infusion or Flow Problem (2964); Pressure Problem (3012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/30/2021 |
Event Type
malfunction
|
Event Description
|
Spontaneous call from patient's husband who reports he is changing the cassette and tubing and got a high-pressure alarm.Spouse confirmed that all damps were open and there were no kinks in the line.Discussed with spouse that he could try back up pump and see if the same thing happened or try a new tubing.Spouse connected a new tubing set and was able to continue infusion with no issue.Serial# (b)(4); did the reported product fault occur while in use with the patient? yes; did the product issue cause or contribute to patient or clinical injury? no; is the actual device available for investigation? no; did we replace device? no; did the patient have a backup device they were able to switch to? yes; if yes, was the patient able to successfully continue their infusion? yes.Reported to (b)(6) by pt/caregiver.
|
|
Search Alerts/Recalls
|
|
|