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

Model Number A015(H5)/V609(H5)

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation attached is on retained samples only.Manufacturer is waiting for actual sample in order to complete a final investigation.

Event Description

After completion of dialysis treatment, staff started to return the patient's blood and noticed a clot past the venous chamber.Staff clamped the tube immediately to stop the clot from flowing in through the patient's access.

Event Description

After completion of dialysis treatment, staff started to return the patient's blood and noticed a clot past the venous chamber.Staff clamped the tube immediately to stop the clot from flowing in through the patient's access.

Manufacturer Narrative

Investigation attached is on retained samples only.Manufacturer is waiting for actual sample in order to complete a final investigation.- attachment: [initial investigation report (18-16-h5-tu).Pdf, final investigation report (18-16-h5-tu).

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOODLINE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya, , 13110 ; TH 13110
• MDR Report Key: 8191671
• MDR Text Key: 131932036
• Report Number: 8041145-2018-00019
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: A015(H5)/V609(H5)
• Device Lot Number: 18H05
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other