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

Model Number A364R-V850R-GT

Device Problems Connection Problem (2900); Separation Problem (4043)

Patient Problems Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 10/10/2023

Event Type  Death  

Event Description

On (b)(6) 2023, the dialysis machine gave an arterial pressure alarm at 1:55 p.M.The nurse in charge found the patient lying in bed dying in a pool of blood.The venous branch to the permcath right subclavian vein was disconnected, the arterial branch was intact.Dialysis ran for a total of 55 minutes before the event.10 minutes before, the machine gave a single venous pressure alarm.The alarm was checked and reset and did not occur again afterwards.Resuscitation was carried out immediately and the venous limb was reconnected and transfusion and volume administration were carried out, which were ultimately unsuccessful.

• Brand Name: NIPRO BLOOD TUBING SET W/TP
• 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: 18139430
• MDR Text Key: 328155109
• Report Number: 8041145-2023-00007
• 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: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A364R-V850R-GT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• 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): Death
• Patient Age: 93 YR
• Patient Sex: Male