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

Model Number A015(H5)/V609(H5)

Device Problem Obstruction of Flow (2423)

Patient Problem Blood Loss (2597)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

Final investigation pending.

Event Description

During treatment, staff noticed a clot past the venous chamber.Staff immediately clamped the line to prevent the clot from entering the patient.Dialysis conditions: 3.5 hour treatment.Bfr: 150 min/ml.Dfr: 300 min/ml.Meds: heparin dose 5000 units.Other devices used: safetouch ii avf needle.Fmc 4008b dialysis machine.

Manufacturer Narrative

Initial investigation report.Final investigation pending.08/04/2020: final investigation report is on retained samples only.

Event Description

During treatment, staff noticed a clot past the venous chamber.Staff immediately clamped the line to prevent the clot from entering the patient.Dialysis conditions: 3.5 hour treatment, bfr: 150 min/ml, dfr: 300 min/ml.Meds: heparin dose 5000 units.Other devices used: safetouch ii avf needle, fmc 4008b dialysis machine.

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOODLINES
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• MDR Report Key: 10306181
• MDR Text Key: 203895516
• Report Number: 8041145-2020-00008
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A015(H5)/V609(H5)
• Device Lot Number: 19K18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention