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	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Blood Loss (2597); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number unknown, actual used device is to be returned for investigation, still pending.
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.
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.
Additional Manufacturer Narrative
Lot number unknown, actual used device is to be returned for investigation, still pending.11/19/19: manufacturer investigation report attached is on both retained and returned actual used sample.
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.
Additional Manufacturer Narrative
Lot number unknown, actual used device is to be returned for investigation, still pending.11/19/19: manufacturer investigation report atached is on both retained and returned actual used sample.12/02/2020: the initial report inadvertently included the importer report number and was mistakenly labeled as a single mdr report.The patient code (b)(6) in section is a retired code, therefore new codes were added in the "health effect impact code" and "health effect clinical code.".

• 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: 9226990
• Report Number: 8041145-2019-00009
• Device Sequence Number: 16628148
• Product Code: FJK
• UDI-Device Identifier: 00383790004053
• UDI-Public: 00383790004053
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2020
• 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 Catalogue Number: BL+A209Y/V803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• 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: 10/01/2019
• Supplement Date Received by Manufacturer: 10/01/2019; 10/01/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/19/2019; 12/03/2020
• 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
• Date Report Sent to FDA: 10/23/2019