MAUDE Adverse Event Report: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"; CATHETER,INTRAVASCULAR,THERAP

Catalog Number ASK-42703-PVCC

Device Problem Biocompatibility (2886)

Patient Problem Anaphylactic Shock (1703)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: ine, rocuronium.Qn# (b)(4).

Event Description

Patient is a (b)(6) year old male who presented for elective mitral valve repair, tricuspid repair and left atrial appendage excision.Patient received cefazolin, sufentanil, midazolam, propofol, lidocaine, rocuronium, and chlorhexidine impregnated central line.Within 30 minutes of induction, patient developed refractory hypotension and peri-arrest situation.Treatment included 3 l1 of iv fluid, initially received a bolus of norepinephrine and was maintained on an epi infusion.Later changed to chlorhexidine free cvc.Intraoperative tryptase level was 22 which remained positive 6 hours later at 22 which likely was due to "renal failure and impair repaired clearance".Patient had no prior known drug allergies.Patient underwent allergy testing and was confirmed to have a chlorhexidine allergy with skin prick testing to chlorhexidine 2% strong positive at 10x2 mm with underlying erythema and intradermal chlorhexidine 0.002mg/ml at 10mm with underlying erythema.Patient tested negative to cefazolin, cisastracurium, rocuronium, suxamethonium, propofol, midazolam, and fentanyl.Patient's anaphylaxis was most likely caused by the chlorhexidine on the central line.Patient condition reported to be fine.

Manufacturer Narrative

Continuation of d11: ine, rocuronium (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The agba insert provided with this kit states: "the arrowg+ard blue advance antimicrobial/anti-thrombogenic catheter is contraindicated for patients with known hypersensitivity to chlorhexidine." the card also instructs, "perform sensitivity testing to confirm allergy to catheter antimicrobial agents if adverse reaction occurs." the instructions-for-use (ifu) provided with this kit state the following: "clinical assessment of patient must be completed to ensure no contraindications exist e.G.Allergies." the tegaderm chg labeling provided with this kit includes the following warnings and instructions for the user: "do not use this product on patients with known hypersensitivity to chlorhexidine gluconate.The use of chlorhexidine gluconate containing products has been reported to cause irritations, sensitization, and generalized allergic reactions." "hypersensitivity reactions associated with topical use of chlorhexidine gluconate have been reported in several countries.The most serious reactions (including anaphylaxis) have occurred in patients treated with lubricants containing chlorhexidine gluconate, which were used during urinary tract procedures.Preparations of this type are not approved for sale in the u.S.Under any circumstances.Caution should be taken when using chlorhexidine gluconate containing preparations, and the patient should be observed for the possibility of hypersensitivity reactions." "failure to follow the manufacturer's instructions for use may result in complications including skin irritation and/or maceration." the customer report of an allergic reaction was confirmed by the event details of the reported complaint.The patient had an allergic reaction and later was confirmed to have a chlorhexidine allergy.Chlorhexidine is included in the coating of the catheter in this kit.A device history record review was performed based on a potential lot number from sales history and no relevant findings were identified.The labeling provided states the arrowg+ard blue advance antimicrobial/antithrombogenic catheter is contraindicated for patients with known hypersensitivity to chlorhexidine.The labeling also instructs users to "perform sensitivity testing to confirm allergy to catheter antimicrobial agents if adverse reaction occurs." based on the information provided, unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Patient is a 61 year old male who presented for elective mitral valve repair, tricuspid repair and left atrial appendage excision.Patient received cefazolin, sufentanil, midazolam, propofol, lidocaine, rocuronium, and chlorhexidine impregnated central line.Within 30 minutes of induction, patient developed refractory hypotension and peri-arrest situation.Treatment included 3 l1 of iv fluid, initially received a bolus of norepinephrine and was maintained on an epi infusion.Later changed to chlorhexidine free cvc.Intraoperative tryptase level was 22 which remained positive 6 hours later at 22 which likely was due to "renal failure and impair repaired clearance".Patient had no prior known drug allergies.Patient underwent allergy testing and was confirmed to have a chlorhexidine allergy with skin prick testing to chlorhexidine 2% strong positive at 10x2 mm with underlying erythema and intradermal chlorhexidine 0.002mg/ml at 10mm with underlying erythema.Patient tested negative to cefazolin, cisastracurium, rocuronium, suxamethonium, propofol, midazolam, and fentanyl.Patient's anaphylaxis was most likely caused by the chlorhexidine on the central line.Patient condition reported to be fine.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• MDR Report Key: 12600636
• MDR Text Key: 279539852
• Report Number: 9680794-2021-00497
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ASK-42703-PVCC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CEFAZOLIN, SUFENTANIL, MIDAZOLAM, PROPOFOL, LIDOCA; CEFAZOLIN, SUFENTANIL, MIDAZOLAM, PROPOFOL, LIDOCA
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR