Catalog Number CA-27702 |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problems
Erythema (1840); Low Blood Pressure/ Hypotension (1914); Anaphylactoid (2218)
|
Event Date 10/09/2023 |
Event Type
Injury
|
Event Description
|
It was reported that: (b)(6) 2023, after catheterization in the surgical centre, blood pressure decreased, skin turned red, and allergic shock occurred.After receiving vasoactive drugs and anti-allergic therapy to replenish blood volume, hormone therapy, and other treatments, the patient's vital signs gradually stabilized before undergoing surgery.The vital signs remained stable during the surgery and patient was returned to the ward after the surgery.There was a delay to surgery but patient was reported as good post the procedure.
|
|
Manufacturer Narrative
|
Qn#(b)(4).
|
|
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.The instructions for use (ifu) provided with this kit warns the user, "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs.Remove catheter immediately if adverse reactions occur after catheter placement.Chlorhexidine containing compounds have been used as topical disinfectants since the mid-1970's.An effective antimicrobial agent, chlorhexidine found use in many antiseptic skin creams, mouth rinses, cosmetic products, medical devices and disinfectants used to prepare the skin for a surgical procedure.Note: perform sensitivity testing to confirm allergy to catheter antimicrobial agents, if adverse reaction occurs." the complaint of catheter related allergic reaction could not be confirmed.No sample was returned for investigation.The customer did not report that allergy testing was performed to confirm a chlorhexidine allergy.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.Therefore, 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: on (b)(6) 2023, after catheterization in the surgical centre, blood pressure decreased, skin turned red, and allergic shock occurred.After receiving vasoactive drugs and anti-allergic therapy to replenish blood volume, hormone therapy, and other treatments, the patient's vital signs gradually stabilized before undergoing surgery.The vital signs remained stable during the surgery and patient was returned to the ward after the surgery.There was a delay to surgery but patient was reported as good post the procedure.
|
|
Search Alerts/Recalls
|
|