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

Model Number NS-2110-39A

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem Hemolytic Anemia (2279)

Event Date 03/14/2022

Event Type  malfunction  

Event Description

2l of blood leaked from the shunt joint part.It was considered that the needle and the blood tubing set had not been connected properly.By the time the customer noticed the leak, the blood circuit and the cannula were already disconnected.Patient was given 1500ml of blood transfusion.No further information was provided.

Event Description

2l of blood leaked from the shunt joint part.It was considered that the needle and the blood tubing set had not been connected properly.By the time the customer noticed the leak, the blood circuit and the cannula were already disconnected.Patient was given 1500ml of blood transfusion.No further information was provided.

• Brand Name: NIPRO BLOOD TUBING SET
• Type of Device: BLOODLINE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 13998158
• MDR Text Key: 298284250
• Report Number: 8041145-2022-00002
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NS-2110-39A
• Device Lot Number: 21L21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• 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): Required Intervention