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

Model Number	BL+A209Y/V803
Medical Device Problem Codes	Obstruction of Flow (2423); Pumping Problem (3016)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
3 total events occurred, blood line clotted on fresenius 2008k machine.The patient care technician notified notified the senior biomedical engineer after the patient was disconnected.The bloodline was still on the dialysis machine.Tech stated there was no alarm, the blood pump was spinning at 300 ml/min and the blood was not moving due to the clotting.
Event or Problem Description
3 total events occurred, blood line clotted on fresenius 2008k machine.The patient care technician notified notified the senior biomedical engineer after the patient was disconnected.The bloodline was still on the dialysis machine.Tech stated there was no alarm, the blood pump was spinning at 300 ml/min and the blood was not moving due to the clotting.

• 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
• MDR Report Key: 10083595
• Report Number: 8041145-2020-00006
• Device Sequence Number: 11469858
• Product Code: FJK
• UDI-Device Identifier: 00383790004053
• UDI-Public: 00383790004053
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072024
• Number of Events Summarized: 1
• Summary Report (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): 06/19/2020

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: 07/31/2024
• Device Model Number: BL+A209Y/V803
• Device Catalogue Number: BL+A209Y/V803
• Device Lot Number: 19K09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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