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

Model Number BL+A209Y/V803

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Low Oxygen Saturation (2477)

Event Date 01/06/2024

Event Type  Death  

Event Description

Patient's bp dropped to 93/49 about 15 mins before end of treatment.O2 saturation dropped to 80% and medical emergency activated, 911 called.Patient became unconscious with no pulse.Investigation on dialysis products involved when patient expired during treatment per facility policy.Used blood line saved by facility for investigation.Other devices used: nipro safe touch tulip, code and lot unknown.Dialysis settings: 3 hrs, 2k2.5ca, bfr 350, dfr 700, 3x/ week treatment.

• 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,
• MDR Report Key: 18794478
• MDR Text Key: 336393279
• Report Number: 1056186-2024-00003
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL+A209Y/V803
• Device Lot Number: 22F22
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2024
• Distributor Facility Aware Date: 02/13/2024
• Device Age: 19 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 73 KG