MAUDE Adverse Event Report: NIPRO (THAILAND) CORP., LTD. NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR; BLOODLINE

Model Number A367TR/V853TR

Device Problems Leak/Splash (1354); Connection Problem (2900); Device Dislodged or Dislocated (2923)

Patient Problem Blood Loss (2597)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation report attached is on retained samples only.Device discarded.

Event Description

After 15 minutes into hemodialysis treatment, nurse found bloodline disconnected between the venous connection and the patient's canaud catheter.Blood leak occurred.Approximate amount of 300ml of blood was lost.No further information was provided.

Manufacturer Narrative

Investigation report attached is on retained samples only.On (b)(6) 2016: additional investigation report attached on returned unused samples of other medical devices used during incident.

Event Description

After 15 minutes into hemodialysis treatment, nurse found bloodline disconnected between the venous connection and the patient's canaud catheter.Blood leak occurred.Approximate amount of 300ml of blood was lost.No further information was provided.

• Brand Name: NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR
• Type of Device: BLOODLINE
• 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: 5873555
• MDR Text Key: 52065966
• Report Number: 8041145-2016-00019
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: A367TR/V853TR
• Device Lot Number: 14K18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• 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
• Patient Outcome(s): Other