MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number	IPN921104
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Air Embolism (1697); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)
Date of Event	08/01/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Complaint from hospital reports: "in response to emergency alarm being triggered in bed space.Attended to find patient unresponsive, hypoxic, and bradycardic and hypotensive.Had recently been disconnected from hemofiltration machine, likely air emboli." the bedside nurse reported "she had clamped both access and return line when she was required to discontinue filtration treatment due to a water insufficiency.She then attended to the machine, on return to the patient she found him gasping and unresponsive.She noted that blood was coming out of the blue return line and it was no longer clamped.She immediately re-clamped it and alerted the emergency call bell." it was reported the patient was positioned head down, given meter aminol bolus doses and fluid bolus.Patient was intubated, ventilated with 100% o2, had cardiovascular instability, was severely hypotensive, and given adrenaline 1mg bolus doses."cvc line sited for additional medications.Sedation commenced.Stability achieved".A bedside echo showed global poor contraction and bradycardia at 40 bpm, no rv dilation or strain, and echo bubbles in rv and ra (no central fluid running at the time).It was reported the patient was deceased.Additional information received 19sep2023: the patient died on (b)(6) 2023.The patient's cause of death "has been referred to the coroner" and "current notification of multi-organ failure, bleed following coeliac angiogram and recombinant tissue plasminogen activators, hepatic ischemia, liver transplant, air entrainment via vascath, hepatocellular carcinoma, alcohol related liver disease/fatty liver disease, diabetes".The air embolism occurred on (b)(6) 2023 and was detected immediately by patient's significant deterioration.Bubbles were seen in the right ventricle and right atrium on echocardiogram.The hospital reported "this patient has suffered an air embolus from entrainment of air through his central venous line which was a dual lumen vascath.The temporal relationship associated with the symptoms, as well as the objective echocardiography images that shows their was air within the right side of the heart.Based on the information we have this seems to be related to the failure of the clamp and also a bung not being placed at the end of the line.The patient ultimately died from hepatic ischemia due to complications from his liver transplant.This was not related to the air embolus directly.However there is no doubt that the failure of the clamp and a bung not being placed caused an air embolus that led to cardiac arrest.".
Event or Problem Description
Complaint from hospital reports: "in response to emergency alarm being triggered in bed space.Attended to find patient unresponsive, hypoxic, and bradycardic and hypotensive.Had recently been disconnected from hemofiltration machine, likely air emboli." the bedside nurse reported "she had clamped both access and return line when she was required to discontinue filtration treatment due to a water insufficiency.She then attended to the machine, on return to the patient she found him gasping and unresponsive.She noted that blood was coming out of the blue return line and it was no longer clamped.She immediately re-clamped it and alerted the emergency call bell." it was reported the patient was positioned head down, given meter aminol bolus doses and fluid bolus.Patient was intubated, ventilated with 100% o2, had cardiovascular instability, was severely hypotensive, and given adrenaline 1mg bolus doses."cvc line sited for additional medications.Sedation commenced.Stability achieved".A bedside echo showed global poor contraction and bradycardia at 40 bpm, no rv dilation or strain, and echo bubbles in rv and ra (no central fluid running at the time).It was reported the patient was deceased.Additional information received 19sep2023: the patient died on (b)(6) 2023.The patient's cause of death "has been referred to the coroner" and "current notification of multi-organ failure, bleed following coeliac angiogram and recombinant tissue plasminogen activators, hepatic ischemia, liver transplant, air entrainment via vascath, hepatocellular carcinoma, alcohol related liver disease/fatty liver disease, diabetes".The air embolism occurred on (b)(6) 2023 and was detected immediately by patient's significant deterioration.Bubbles were seen in the right ventricle and right atrium on echocardiogram.The hospital reported "this patient has suffered an air embolus from entrainment of air through his central venous line which was a dual lumen vascath.The temporal relationship associated with the symptoms, as well as the objective echocardiography images that shows their was air within the right side of the heart.Based on the information we have this seems to be related to the failure of the clamp and also a bung not being placed at the end of the line.The patient ultimately died from hepatic ischemia due to complications from his liver transplant.This was not related to the air embolus directly.However there is no doubt that the failure of the clamp and a bung not being placed caused an air embolus that led to cardiac arrest.".
Additional Manufacturer Narrative
(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 two potential lot numbers taken from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "pinch clamp(s) are provided on extension lines to occlude flow through each lumen during line and luer-lock connector changes.Warning: do not leave open needles or uncapped, unclamped catheters in central venous puncture site.Air embolism can occur if air is allowed to enter a central venous access device or vein." 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.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17842154
• Report Number: 3006425876-2023-00918
• Device Sequence Number: 7173318
• Product Code: MPB
• UDI-Device Identifier: 00801902100191
• UDI-Public: 00801902100191
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN921104
• Device Catalogue Number: CS-22142-F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Outcome Attributed to Adverse Event: Required Intervention; Death; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 104 KG