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

Model Number	BL+A209Y/V803
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Rn checked machine due to alarm, noted air in the lines, checked to see if chambers were low and they were not, moved over lines to check for faults and blood was noted coming out of the pump.Lines were clamped and no blood was returned due to a tear in the lines.Patient was stable bp 136/58, pulse 54.Patient was told that there was a problem with the lines and they needed to be changed, patient was clam.Lines were taken off the machine, double bagged in biohazard bags with original packaging.Machine was cleaned and newlines were primed, treatment restarted w/o further incident.Estimated 400 cc blood loss, md aware, v/s 155/64 pulse 54, patient alert and oriented w/o complaints closely monitor for any blood infection draw cbc on sat.
Event or Problem Description
Rn checked machine due to alarm, noted air in the lines, checked to see if chambers were low and they were not, moved over lines to check for faults and blood was noted coming out of the pump.Lines were clamped and no blood was returned due to a tear in the lines.Patient was stable bp 136/58, pulse 54.Patient was told that there was a problem with the lines and they needed to be changed, patient was clam.Lines were taken off the machine, double bagged in biohazard bags with original packaging.Machine was cleaned and newlines were primed, treatment restarted w/o further incident.Estimated 400 cc blood loss, md aware, v/s 155/64 pulse 54, patient alert and oriented w/o complaints closely monitor for any blood infection draw cbc on sat.

• 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: 15538875
• Report Number: 8041145-2022-00010
• Device Sequence Number: 7046498
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown