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U.S. Department of Health and Human Services

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

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NIPRO (THAILAND) CORP. LTD. NIPRO BLOOD TUBING SET W/TP; BLOODLINE Back to Search Results
Model Number BL+A430/V912
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2023
Event Type  malfunction  
Event Description
During dialysis treatment, machine alarmed instantly for blood leak within the dialyzer, visible in the arterial coupler tubing.Patient was removed from the machine without returning the patient's blood (approximately 250ml of blood loss).Per charge nurse, patient required no follow up or transfusion post incident.Dialyzer used: f250 dialyzer machine: surdial dx hemodialysis system productg code: mc+sdx01 510k: k182940.
 
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Brand Name
NIPRO BLOOD TUBING SET W/TP
Type of Device
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 Key18528019
MDR Text Key333097353
Report Number9610987-2024-00001
Device Sequence Number1
Product Code FJK
UDI-Device Identifier00383790008808
UDI-Public00383790008808
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/17/2024
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
Device Operator Health Professional
Device Model NumberBL+A430/V912
Device Lot Number22C18
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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