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

Model Number	BL+A209Y/V803
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Death
Event or Problem Description
Predialysis, patient was stable, no sob, talked to pct, face edema severe, periorbital edema severe, at 10:34 am bp 94/60 hr 75.Hd tx started , patient vomiting projectile with fluid, agonal breathing, lost conscious, pulse present, patient was turned to left side.Hd tx paused, fluid was rinsed back to patient by pct, patient was put on oxygen 5l nc.911 activated, patient stopped breathing and patient was put on the floor to start cpr.Paramedic arrived and continued cpr for 3 mins before rosc.Patient was transferred to (b)(6) hospital.The nursing home staff was informed by ma.Called family, family did not pick up, left message.
Event or Problem Description
Predialysis, patient was stable, no sob, talked to pct, face edema severe, periorbital edema severe, at 10:34 am bp 94/60 hr 75.Hd tx started , patient vomiting projectile with fluid, agonal breathing, lost conscious, pulse present, patient was turned to left side.Hd tx paused, fluid was rinsed back to patient by pct, patient was put on oxygen 5l nc.911 activated, patient stopped breathing and patient was put on the floor to start cpr.Paramedic arrived and continued cpr for 3 mins before rosc.Patient was transferred to garfield hospital.The nursing home staff was informed by ma.Called family, family did not pick up, left message.

• Brand Name: NIPRO BLOOD TUBING SET W/TP
• Common Device Name: 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: 15540119
• Report Number: 8041145-2022-00011
• Device Sequence Number: 20332751
• Product Code: FJK
• UDI-Device Identifier: 00383790004053
• UDI-Public: 00383790004053
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BL+A209Y/V803
• Device Catalogue Number: BL+A209Y/V803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death; Hospitalization
• Patient Sex: Unknown