MAUDE Adverse Event Report: NIPRO THAILAND CORPORATION LTD. NIPRO BLOOD TUBING SET; BLOOD TUBING SET FOR HEMODIALYSIS

Model Number A230TR/V810TR

Device Problem Detachment Of Device Component (1104)

Patient Problem Death (1802)

Event Date 04/04/2010

Event Type  Death  

Event Description

It was reported that the venous blood tubing became disconnected from the catheter during treatment and the patient died.

• Brand Name: NIPRO BLOOD TUBING SET
• Type of Device: BLOOD TUBING SET FOR HEMODIALYSIS
• Manufacturer (Section D): NIPRO THAILAND CORPORATION LTD.; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO THAILAND CORPORATION LTD.; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya, 1311 0; TH 13110
• Manufacturer Contact: jessica oswald-mcleod ; 3150 nw 107th ave.; doral, FL 33172 ; 3055997174
• MDR Report Key: 4742518
• MDR Text Key: 15238537
• Report Number: 8041145-2015-00009
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A230TR/V810TR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2010
• Initial Date FDA Received: 05/01/2015
• 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
• Patient Outcome(s): Death