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

Model Number	BL+A223D/V809D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was 3 hour 15 minutes into a 4 hour hd treatment when staff stated they observed blood leaking from the blood pump segment on the machine.Reported that hd treatment was stopped and the bloodline and dialyzer was thrown away.Blood was not returned to the patient.She reported that the patient was stable during and after the event.Patient did not require any further medical attention related to this issue.Staff did not retain the bloodline for return to us.

• 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,
• MDR Report Key: 15427956
• Report Number: 1056186-2022-00011
• Device Sequence Number: 4750673
• Product Code: FJK
• UDI-Device Identifier: 00383790004176
• UDI-Public: 00383790004176
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/15/2022
• Report Date (Section F): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: BL+A223D/V809D
• Device Catalogue Number: BL+A223D/V809D
• Device Lot Number: 18D22-8
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/19/2022
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/15/2022