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

Model Number A372R-V858R

Device Problem Disconnection (1171)

Patient Problem Exsanguination (1841)

Event Date 07/24/2021

Event Type  Injury  

Event Description

After approximately 30 minutes into dialysis treatment, the venous blood tubing line disconnected from the leg demersvenous catheter.Patient suffered life-threatening massive blood loss.The patient had to be resuscitated.Plasma expanders and a blood transfusion was administered.Staff states they double checked the connection between the bloodline and catheter before starting the treatment and no damages were noticed to the bloodline connectors.Dialysis settings: blood flow rate: 400ml/min, dialysate flow rate: 500ml/min, ultrafiltration rate: 300ml/h, dif priming 700ml.Other devices: surdial x machine.

• 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: 12310473
• MDR Text Key: 266161742
• Report Number: 8041145-2021-00014
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A372R-V858R
• Device Lot Number: 21B09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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): Life Threatening; Other