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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO AVF TULIP NEEDLE; AVF NEEDLE

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NIPRO (THAILAND) CORP. LTD. NIPRO AVF TULIP NEEDLE; AVF NEEDLE Back to Search Results
Model Number FT+152530BC
Device Problem Disconnection (1171)
Patient Problems Headache (1880); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Blood Loss (2597)
Event Date 01/08/2019
Event Type  Injury  
Event Description
Patient arrived to facility for scheduled hemodialysis treatment, alert and oriented.Pre-dialysis vital signs obtained: b/p 184/107; pulse 77; resp 18; temp 97.5.Hemodialysis treatment was initiated at 05:11.At 06:55, the patient stated she has a headache and was lightheaded; patient requested acetaminophen.B/p was 66/38, pulse 69.The dialysis machine alarmed.The right upper arm avf was covered with a blanket and when the blanket was removed, it was noted that the venous bloodline was disconnected from the venous fistula needle line.Estimated blood loss 500-800ml; blood was noted on the floor, blanket, pillow, and patient's shirt.Blood from the extracorporeal circuit was returned to the patient, and 1000ml of normal saline was administered.Oxygen was administered and 911 called.At 07:00, b/p was 73/35; pulse 69.Patient stated she felt better.At 07:09, b/p 121/64, pulse 64.Emergency medical services arrived at 07:10 and transported patient to the hospital.She was observed for several hours then discharged home.The patient returned to her next scheduled dialysis treatment on (b)(6) 2019.Other devices used: fresenius 2008 t dialysis machine; combiset true flow blood tubing; 160 nre optiflux dialyzer; naturalyte acid 2.0k; 2.0 ca; 1.0 mg; 100 dextrose.Other products used: naturalyte 4000 rx12, bicarbonate (45x); fresenius 1000ml normal saline; 3m micropore plus paper tape.
 
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Brand Name
NIPRO AVF TULIP NEEDLE
Type of Device
AVF NEEDLE
Manufacturer (Section D)
NIPRO (THAILAND) CORP. LTD.
10/2 moo 8, bangnomko, sena
ayuthaya,?, 13110
TH  13110
MDR Report Key8345584
MDR Text Key136493594
Report Number1056186-2019-00002
Device Sequence Number1
Product Code MPB
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 02/15/2019
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 NumberFT+152530BC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/15/2019
Distributor Facility Aware Date01/22/2019
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/15/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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