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

Model Number A372R-V858R

Device Problem Inadequate Filtration Process (2308)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation report attached is on retained samples only.Manufacturer is anticipating the return of the actual used sample.Still pending.

Event Description

During hd mode dialysis treatment the venous pressure began to increase.After 3 hours into treatment, a venous pressure alarm sounded due to the formation of blood clots in the venous chamber.The healthcare professional washed the circuit and at that moment, noticed that a clot passed through the chamber.1000u of heparin was given to the patient and the patient was treated with varfine medication.Staff confirmed there was no patient adverse event.Date of event is unknown.

Event Description

During hd mode dialysis treatment the venous pressure began to increase.After 3 hours into treatment, a venous pressure alarm sounded due to the formation of blood clots in the venous chamber.The healthcare professional washed the circuit and at that moment, noticed that a clot passed through the chamber.1000u of heparin was given to the patient and the patient was treated with varfine medication.Staff confirmed there was no patient adverse event.Date of event is unknown.

Manufacturer Narrative

Investigation report attached is on retained samples only.Manufacturer is anticipating the return of the actual used sample.Still pending.Final investigation report.

• 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: 8813327
• MDR Text Key: 157456171
• Report Number: 8041145-2019-00008
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: A372R-V858R
• Device Lot Number: 19B11
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other