MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER, PERCUTANEOUS

Catalog Number CV-12142-UF

Device Problem Product Quality Problem (1506)

Patient Problems Air Embolism (1697); No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information received: about the gas embolism, the customer discovered the gas embolism and noticed the catheter was not clamped.So, they don't know if it was a device failure or a medical error (they could have forgotten to clamp).The facility solved the issue immediate and took care of the patient.It is reported that the patient is fine.The customer said it was difficult to clamp with teleflex devices but in the other hand the sales representative performed a demo of the clamp to show them how to do it.They are going to do a fresh training to the staff in september.

Event Description

The customer reports: recently, during an analyses on the patient after a gas embolism during a plasma exchange session in the context of an acute humoral rejection of a pulmonary graft, we had a difficulty to clamp the dialysis catheter.

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 was performed and no relevant findings were identified.The instructions-for-use provided with this kit warns the user, "the practitioner must be aware of potential air embolism/hemorrhage associated with large-bore catheters.Do not leave open needles or catheters in central venous puncture sites.To lessen the risk of disconnects, only securely tightened luer-lock connections should be used with this device.It is recommended that the extension lines be kept clamped at all times when not in use because of the catheter's large lumens.Follow hospital protocol to guard against air embolism/hemorrhage for all catheter maintenance." 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.

Event Description

The customer reports: recently, during an analyses on the patient after a gas embolism during a plasma exchange session in the context of an acute humoral rejection of a pulmonary graft, we had a difficulty to clamp the dialysis catheter.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10245345
• MDR Text Key: 197960771
• Report Number: 3006425876-2020-00616
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 06/25/2020

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: No Information
• Device Catalogue Number: CV-12142-UF
• Device Lot Number: 71F19L1361
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other