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

Model Number	BL+A223D/V809D
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the 1st minute of treatment, a physical leak was noted on the blood pump, treatment stopped, blood was not returned.New set up done using same lot #, different machine and finished treatment with no issues.Patient lost 200ml of blood.No hospitalization.Hbg rechecked, no data on baseline hgb and no result yet.Iv antibiotics started as a prophylaxis.The biomed also checked the machine and ordered some parts of the blood pump segment.The manager also mentioned that they just had a recall of some of the machines because of issues with the blood pump segment.Other devices used: fresenius 2008t.
Event or Problem Description
During the 1st minute of treatment, a physical leak was noted on the blood pump, treatment stopped, blood was not returned.New set up done using same lot #, different machine and finished treatment with no issues.Patient lost 200ml of blood.No hospitalization.Hbg rechecked, no data on baseline hgb and no result yet.Iv antibiotics started as a prophylaxis.The biomed also checked the machine and ordered some parts of the blood pump segment.The manager also mentioned that they just had a recall of some of the machines because of issues with the blood pump segment.Other devices used: fresenius 2008t.

• 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: 16164902
• Report Number: 8041145-2022-00015
• Device Sequence Number: 7507665
• Product Code: FJK
• UDI-Device Identifier: 00383790004176
• UDI-Public: 00383790004176
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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+A223D/V809D
• Device Catalogue Number: BL+A223D/V809D
• Device Lot Number: 22E19-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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