Catalog Number SAC-00818-PBX |
Device Problems
Unable to Obtain Readings (1516); Obstruction of Flow (2423)
|
Patient Problems
Pain (1994); Discomfort (2330)
|
Event Date 03/05/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn#(b)(4).
|
|
Event Description
|
It was reported that the :incident occured on (b)(6) 2023 in the rescucitation department.Involved a 41 year old female patient, weight 66 kg.The arterial catheter was inserted on (b)(6) 2023.After 24 hours it was dysfunctional: it was impossible to sample blood and get the reading of arterial pressure.Consequence: blood pressure was measured manually, which is not comfortable for the patient.A second arterial catheter was inserted to solve the issue.Device was discarded." additional information stated that arterial line was repositioned prior to manual measurement.No harm or consequence to patient reported.Patient condition reported as "stable".
|
|
Manufacturer Narrative
|
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
|
|
Event Description
|
It was reported that the :incident occured on 05 march 2023 in the resuscitation department.Involved a 41 year old female patient, weight 66 kg.The arterial catheter was inserted on (b)(6) 2023.After 24 hours it was dysfunctional: it was impossible to sample blood and get the reading of arterial pressure.Consequence: blood pressure was measured manually, which is not comfortable for the patient.A second arterial catheter was inserted to solve the issue.Device was discarded." additional information stated that arterial line was repositioned prior to manual measurement.No harm or consequence to patient reported.Patient condition reported as "stable".
|
|
Search Alerts/Recalls
|