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

Model Number	BL+A430/V912
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Confusion/ Disorientation (2553)
Date of Event	10/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation report attached is on retained samples by the manufacturer only.Pending completion of final investigation on returned sample.
Event or Problem Description
Approximately 2 hours into dialysis treatment a patient had significant blood loss from venous needle connection.Facility administrator stated the connection was loose.They placed towels on the floor surrounding the blood and estimated 2-24 inches of blood.Vitals taken at 11:30am were stable and access was visualized.At about 11:45am, patient seemed confused and blood pressure was 70/38.The team was able to secure the line and return the patient's blood.Patient was then sent to the hospital for blood transfusion and observation, subsequently requiring 2nd blood transfusion.Patient returned to regular dialysis treatment on (b)(6) 2022 without complications.Other devices used: nipro surdial dx hemodialysis system, serial# (b)(4), udi: (b)(4).
Event or Problem Description
Approximately 2 hours into dialysis treatment a patient had significant blood loss from venous needle connection.Facility administrator stated the connection was loose.They placed towels on the floor surrounding the blood and estimated 2-24 inches of blood.Vitals taken at 11:30am were stable and access was visualized.At about 11:45am, patient seemed confused and blood pressure was 70/38.The team was able to secure the line and return the patient's blood.Patient was then sent to the hospital for blood transfusion and observation, subsequently requiring 2nd blood transfusion.Patient returned to regular dialysis treatment on (b)(6) 2022 without complications.Other devices used: nipro surdial dx hemodialysis system, serial# (b)(6), udi: (b)(4).
Additional Manufacturer Narrative
Investigation report attached is on retained samples by the manufacturer only.Pending completion of final investigation on returned sample.Final investigation report attached is on retained samples and unused returned samples only.Actual device was discarded.

• 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: 15811358
• Report Number: 8041145-2022-00012
• Device Sequence Number: 5613312
• Product Code: FJK
• UDI-Device Identifier: 00383790008808
• UDI-Public: 00383790008808
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 12/31/2025
• Device Model Number: BL+A430/V912
• Device Catalogue Number: BL+A430/V912
• Device Lot Number: 21A11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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; Hospitalization
• Patient Sex: Unknown