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

Model Number A252R/V777R

Device Problem Kinked (1339)

Patient Problems Fistula (1862); Hemolysis (1886); Nausea (1970); Vomiting (2144); Malaise (2359)

Event Date 02/18/2013

Event Type  Injury  

Event Description

2 incidents (2 patients) reported: 1 hour after dialysis treatment was initiated, with a blood flow rate of 400ml/min, both patients with av fistulas, developed, nausea, malaise, epistaxis, vomiting, both patients resulting in hemolysis, both detectable in the blood.Nurse noticed a kink in the blood tubing set in front of the arterial drip chamber about 100mm in length.Both patients were treated immediately in the icu and recovered well.No further information was provided.

Manufacturer Narrative

Manufacturer investigation report on retained and returned samples.

• 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: 4931622
• MDR Text Key: 6028396
• Report Number: 8041145-2015-00052
• 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: 07/22/2013

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: 08/31/2017
• Device Model Number: A252R/V777R
• Device Lot Number: 12I06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2012
• 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): Hospitalization