MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PSI KIT: 8.5 FR; INTERVENTIONAL PSI PRODUCTS

Catalog Number AK-09803-CDC

Device Problems Partial Blockage (1065); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.

Event Description

It was reported the customer has found the psi's have been clotting off while the perfusionist is taking one unit of blood before heart case.This has been occurring since (b)(6) 2016.They have been using this line for over ten years without a problem.No other factors have changed.In the most recent case, the line is much slower to fill the bag and remaining blood in tubing after blood is taken.Perfusionist stated the lines feel different, are more rigid, stiff, and the flow rate has decreased.The tubing on the line is also stiffer and course.There have been delays in treatment and no patient deaths or complications reported.

• Brand Name: PSI KIT: 8.5 FR
• Type of Device: INTERVENTIONAL PSI PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6110418
• MDR Text Key: 60292179
• Report Number: 1036844-2016-00620
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AK-09803-CDC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• 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