Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR; BLOODLINE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NIPRO (THAILAND) CORP. LTD. NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR; BLOODLINE Back to Search Results
Model Number BL+A209Y/V803
Device Problems Obstruction of Flow (2423); Pumping Problem (3016)
Patient Problem Blood Loss (2597)
Event Date 04/24/2020
Event Type  malfunction  
Event Description
3 total events occurred, blood line clotted on fresenius 2008k machine.The patient care technician notified notified the senior biomedical engineer after the patient was disconnected.The bloodline was still on the dialysis machine.Tech stated there was no alarm, the blood pump was spinning at 300 ml/min and the blood was not moving due to the clotting.
 
Event Description
3 total events occurred, blood line clotted on fresenius 2008k machine.The patient care technician notified notified the senior biomedical engineer after the patient was disconnected.The bloodline was still on the dialysis machine.Tech stated there was no alarm, the blood pump was spinning at 300 ml/min and the blood was not moving due to the clotting.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10083595
MDR Text Key191860907
Report Number8041145-2020-00006
Device Sequence Number1
Product Code FJK
UDI-Device Identifier00383790004053
UDI-Public00383790004053
Combination Product (y/n)N
PMA/PMN Number
K072024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBL+A209Y/V803
Device Catalogue NumberBL+A209Y/V803
Device Lot Number19K09
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2020
Date Manufacturer Received04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-