MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR

Model Number A296R/V806R

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem Blood Loss (2597)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

Investigation report on retained samples only, product was not returned to the manufacturer.

Event Description

After approximately 20-30 minutes into treatment, the nurse realized there was a blood leak on the blood tubing set.Blood leaked on both sides of the heparin line.The patient lost more than 500ml of blood and required a blood transfusion of 500ml.No further information was provided.Other devices used during incident: fresenius 4008 dialysis machine.

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOOD TUBING SET
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 5499680
• MDR Text Key: 40299836
• Report Number: 8041145-2016-00009
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: A296R/V806R
• Device Lot Number: 15C26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention