MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR; 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	Serious Injury
Additional Manufacturer Narrative
Investigation report is on retained samples by the manufacturer.Unused samples are being returned by the customer.Will attach to follow up submission.
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.
Additional Manufacturer Narrative
Investigation report attached is on retained samples by the manufacturer.Unused samples are being returned by the customer.Will attach to follow up submission.10/07/2022: final investigation report attached is on unused samples from same lot, returned by the customer.
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/TRANSDUCER PROTECTOR
• 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: 15428111
• Report Number: 8041145-2022-00008
• Device Sequence Number: 20760468
• Product Code: FJK
• UDI-Device Identifier: 00383790004176
• UDI-Public: 00383790004176
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K182940
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2018
• 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: Other
• Patient Sex: Unknown