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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  Injury  
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,
MDR Report Key18527881
MDR Text Key333051301
Report Number1056186-2024-00001
Device Sequence Number1
Product Code FJK
UDI-Device Identifier00383790008808
UDI-Public00383790008808
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2024
Distributor Facility Aware Date12/21/2023
Device Age21 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/17/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/17/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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