MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 11CM; CATHETER,INTRAVASCULAR,THERAP

Model Number IPN030623

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: it was reported that, "central line inserted to allow infusion of medications that require central access for safe administration.Central line inserted into right internal jugular under ultrasound guidance without incident.Packaging of central line was intact on visual inspection, and equipment did not have any obvious faults.3-way taps provided as part of the central line pack were connected to ports.Noradrenaline was connected to 3-way tap, but despite increasing infusion rate, there was insufficient clinical response.Adrenaline infusion then started via other port on the same 3-way tap as the noradrenaline, but similarly clinical response was not as expected given infusion rates.Visual inspection of the port / line being used; noticed air bubbles in line distal to the three way tap (small volume, but ~2cm of line per bubble with combined infusion rate of medications at 20mls/hr.) same issue not occurring on another port/3-way tap being used for sedation.No injury or harm to patient; near miss." it was reported infusions were immediately stopped and blood pressure supported by peripheral adrenaline boluses.The line was aspirated to remove air and a new 3-way lumen was connected and infusions restarted.No further bubbles observed.It was reported "given amount of time infusions running (less than 5 minutes) and size of bubbles observed, patient not felt to have had a significant amount of air entrained into venous system that would cause clinical issues.Already receiving high level clinical monitoring as under anaesthesia, and this was continued.".

Event Description

The complaint is reported as: it was reported that "central line inserted to allow infusion of medications that require central access for safe administration.Central line inserted into right internal jugular under ultrasound guidance without incident.Packaging of central line was intact on visual inspection, and equipment did not have any obvious faults.3-way taps provided as part of the central line pack were connected to ports.Noradrenaline was connected to 3-way tap but despite increasing infusion rate there was insufficient clinical response.Adrenaline infusion then started via other port on the same 3-way tap as the noradrenaline, but similarly clinical response was not as expected given infusion rates.Visual inspection of the port / line being used; noticed air bubbles in line distal to the three way tap (small volume, but ~2cm of line per bubble with combined infusion rate of medications at 20mls/hr.) same issue not occurring on another port/3-way tap being used for sedation.No injury or harm to patient- near miss." it was reported infusions were immediately stopped and blood pressure supported by peripheral adrenaline boluses.The line was aspirated to remove air and a new 3-way lumen was was connected and infusions restarted.No further bubbles observed.It was reported "given amount of time infusions running (less than 5 minutes) and size of bubbles observed, patient not felt to have had a significant amount of air entrained into venous system that would cause clinical issues.Already receiving high level clinical monitoring as under anaesthesia, and this was continued.".

Manufacturer Narrative

Qn#(b)(4).The customer returned a stopcock from br-20854 cvc set: 4-lumen 8.5fr x 11cm for investigation.The catheter was not returned.Visual analysis of the stopcock did not reveal any defects or anomalies.Visual analysis could not be performed on the catheter as it was not returned for analysis.The stopcock was functionally tested by attaching each luer to a lab inventory syringe filled with water.When the plunger of the syringe was depressed, no leaks were observed.The stopcocks have 3 ports.Two ports have female luers (covered with a dust cap) and one port has a male luer.The male luer was able to be securely connected to the proximal, distal and medial extension lines of a lab inventory catheter.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not suture directly to outside diameter of catheter to minimize the risk of cutting or damaging the catheter or impeding catheter flow." "to minimize the risk of damage to extension lines from excessive pressure, each clamp must be opened prior to infusing through that lumen." "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested".The customer report of extension line leak could not be confirmed by complaint investigation of the returned sample.Only the stopcock was returned.The catheter was not returned.Visual and functional inspection of the stopcock did not reveal any defects or anomalies.A device history record review was performed with no relevant findings.The probable cause of this issue could not be determined without the catheter to evaluate.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 11CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10837784
• MDR Text Key: 216877274
• Report Number: 3006425876-2020-00952
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K962577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Model Number: IPN030623
• Device Catalogue Number: BR-20854
• Device Lot Number: 71F20C1344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADRENALINE AND NORADRENALINE; ADRENALINE AND NORADRENALINE