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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/TRANSDUCER PROTECTOR; BLOODLINE
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NIPRO (THAILAND) CORP. LTD. NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR; BLOODLINE Back to Search Results
Model Number A004HD/V600HD
Device Problem Inadequate Filtration Process (2308)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2020
Event Type  malfunction  
Manufacturer Narrative
Initial investigation report attached is on retained representative samples only.
 
Event Description
After completion of dialysis treatment, auto reinfusion was initiated and a blood clot was found in the artery line of the avf needle, prior to entering the patient.Auto reinfusion was stopped and the clot was removed with a syringe.
 
Event Description
After completion of dialysis treatment, auto reinfusion was initiated and a blood clot was found in the artery line of the avf needle, prior to entering the patient.Auto reinfusion was stopped and the clot was removed with a syringe.
 
Manufacturer Narrative
Initial investigation report attached is on retained representative samples only.
 
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Brand Name
NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
Type of Device
BLOODLINE
Manufacturer (Section D)
NIPRO (THAILAND) CORP. LTD.
10/2 moo 8
bangnomko,
sena, ayuthaya 13110 ,
TH  13110,
MDR Report Key11159707
MDR Text Key241700959
Report Number8041145-2021-00001
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
PMA/PMN Number
K072024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA004HD/V600HD
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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