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

Model Number	BL+A209Y/V803
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Noted blood leaking on a patient blood tubing set, at the blood pump area, upon inspecting, noted a tear on the blood pump segment of the blood tubing set and blood was leaking, about 250cc total blood loss.Device lot number was not recorded.Notified biomed, he noted that the blood pump rotor was missing the guides for the blood lines and may or may not have caused the tear.Biomed was able to change the malfunctioned part, the treatment was resumed with new lines, the patient was asymptomatic, vital signs were stable, and patient was able to finish treatment without problems, facility administrator and physician was made aware of the event.The patient did return for their next scheduled treatment without issues.

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Common Device Name: BLOODLINES
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,?,
• MDR Report Key: 9714612
• Report Number: 8041145-2019-00019
• Device Sequence Number: 16979700
• 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
• Report Date (Section B): 02/14/2020

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 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: 01/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 02/14/2020
• 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