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

Model Number A252R/V777R

Device Problems Kinked (1339); Pressure Problem (3012)

Patient Problems Abdominal Pain (1685); Hemolysis (1886); Test Result (2695)

Event Date 08/14/2014

Event Type  Injury  

Event Description

After 2 hours of initiation of dialysis treatment, nurse performed hourly checking of bloodlines, everything was ok, 15 minutes later the nurse heard a "sucking" sound around the patient and observed a kinking in the arterial line just before entering the arterial chamber, treatment is immediately stopped.Lines are removed for further analysis, the patient complains of abdominal pain, blood is drawn from the patient and hemolysis was confirmed.As the patient is stable, the treatment was restarted in the same machine with new blood lines from the same lot.Patient continued to complain of abdominal pain, patient is sent to the hospital.Reactive pancreatitis.Patient was discharged 6 days after.No further information was provided.

Manufacturer Narrative

Manufacturer investigation result attached.

• 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: 4932358
• MDR Text Key: 6015725
• Report Number: 8041145-2015-00058
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/31/2019
• Device Model Number: A252R/V777R
• Device Lot Number: 14B11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2014
• 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): Hospitalization