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 Patient-Device Incompatibility (2682)

Patient Problem Anaphylactic Shock (1703)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A (b)(6) year old man on hemodialysis for two years presented for a cadaveric renal transplant.At the hospital the operating rooms are set up chlorhexidine free for kidney transplants with chlorhexidine wipes, and soluprep swabs removed from the anesthesia carts.Chlorhexidine free status was confirmed at the time of surgical briefing.After an uneventful induction of anesthesia, a right internal jugular central line was placed.As is local practice the central line was being secured with four sutures.At the time of third skin suture insertion which would be at about 2 minutes after central line insertion, the non-invasive blood pressure cuff displayed 49/29.This blood pressure required large amounts of phenylephrine, vasopressin and epinephrine bolus's to restore.At this time the central line packaging was examined and it noted to be inadvertently a chlorhexidine coated central line.The central line was removed and a few minutes later blood pressure was being adequately maintained on an epinephrine infusion of 100 mcg/ min.A transthoracic echocardiogram was performed showing adequate left ventricular filling, adequate left ventricular contractility without any wall motion abnormalities and a low afterload.The epinephrine was weaned off over the next roughly 70 minutes.The follow up tryptase was markedly elevated with at peak of 27.2, confirming that an anaphylactic reaction had indeed occurred.It was reported the anesthesia resident had assumed (incorrectly) that because the chlorhexidine skin prep solutions had been removed from the anesthesia cart, the central line kit had been changed also to chlorhexidine free.It was reported the resident did not know how to check if the central line contained chlorhexidine and the problem is aside from an orange circle on the packaging the chlorhexidine containing and chlorhexidine free kits look identical.The incident happened 2 minutes post insertion.Surgery was aborted.Present status of patient: the patient is currently under the care of an allergist, has been relisted for another kidney transplant, and had a troponin i high sensitivity peak of 2813 without any known worsening of cardiac function albeit unmeasured.

Event Description

A 70 year old man on hemodialysis for two years presented for a cadaveric renal transplant.At the hospital the operating rooms are set up chlorhexidine free for kidney transplants with chlorhexidine wipes, and soluprep swabs removed from the anesthesia carts.Chlorhexidine free status was confirmed at the time of surgical briefing.After an uneventful induction of anesthesia, a right internal jugular central line was placed.As is local practice the central line was being secured with four sutures.At the time of third skin suture insertion which would be at about 2 minutes after central line insertion, the non-invasive blood pressure cuff displayed 49/29.This blood pressure required large amounts of phenylephrine, vasopressin and epinephrine bolus's to restore.At this time the central line packaging was examined and it noted to be inadvertently a chlorhexidine coated central line.The central line was removed and a few minutes later blood pressure was being adequately maintained on an epinephrine infusion of 100 mcg/ min.A transthoracic echocardiogram was performed showing adequate left ventricular filling, adequate left ventricular contractility without any wall motion abnormalities and a low afterload.The epinephrine was weaned off over the next roughly 70 minutes.The follow up tryptase was markedly elevated with at peak of 27.2, confirming that an anaphylactic reaction had indeed occurred.It was reported the anesthesia resident had assumed (incorrectly) that because the chlorhexidine skin prep solutions had been removed from the anesthesia cart, the central line kit had been changed also to chlorhexidine free.It was reported the resident did not know how to check if the central line contained chlorhexidine and the problem is aside from an orange circle on the packaging the chlorhexidine containing and chlorhexidine free kits look identical.The incident happened 2 minutes post insertion.Surgery was aborted.Present status of patient: the patient is currently under the care of an allergist, has been relisted for another kidney transplant, and had a troponin i high sensitivity peak of 2813 without any known worsening of cardiac function albeit unmeasured.

Manufacturer Narrative

Qn #(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 could not be performed as a valid lot was not provided and a potential lot could not be determined based on a sales history review for this customer.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.The customer did not report details of the patient's allergies or sensitivities.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• MDR Report Key: 12353813
• MDR Text Key: 267667818
• Report Number: 9680794-2021-00441
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-42703-PVCC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 09/29/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR