MAUDE Adverse Event Report: NIPRO THAILAND CORPORATION LTD NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

Model Number A370TR/V856TR

Device Problem Kinked (1339)

Patient Problems Abdominal Pain (1685); Injury (2348)

Event Date 03/04/2015

Event Type  Injury  

Event Description

There was a kink found in the bloodline, the pressure sensor of the switching chamber is clamped and therefore the kinking of the blood line was not detected by the generator (no alarm during dialysis session).Patient injury reported: severe abdominal pain after 3 hours of dialysis, patient put on oxygen, analgesic treatment done.No further information provided, no details on patient outcome.

Manufacturer Narrative

Manufacturer investigation result on retained and returned unused sample only.

• Brand Name: NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
• Type of Device: BLOOD TUBING SET
• Manufacturer (Section D): NIPRO THAILAND CORPORATION LTD; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya 13110, th ; TH
• Manufacturer (Section G): NIPRO THAILAND CORPORATION LTD; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya 13110, th ; TH
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 4932523
• MDR Text Key: 19036064
• Report Number: 8041145-2015-00057
• 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: Foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: A370TR/V856TR
• Device Lot Number: 14J27
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2014
• 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