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

Model Number	BL+A209Y/V803
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
0740am patient care technician noticed blood leak on the blood pump area of the machine.Patient care tech notified the facility administrator, upon inspection noted the tubing on the blood pump had a tear and was leaking blood, staff rinsed back the arterial line, was unable to rinse back venous line due to the leak, patient lost <150cc of blood, staff explained to the patient what had happened, and advised the patient to report any signs and symptoms of anemia, will redraw labs next treatment, new blood lines were set up, and treatment was resumed at 0747am.Blood pressure was within limits, patient denies any complaints.Physician was made aware.Lot number was unknown.

• 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: 9226896
• Report Number: 1056186-2019-00012
• Device Sequence Number: 2549545
• Product Code: FJK
• UDI-Device Identifier: 00383790004053
• UDI-Public: 00383790004053
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2019
• Report Date (Section F): 10/23/2019

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/28/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2019
• 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
• Date Report Sent to FDA: 10/23/2019