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

Model Number FT+152530BC

Device Problems Unintended Ejection (1234); Leak/Splash (1354)

Patient Problems Headache (1880); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Initial investigation report is on representative samples, final investigation is pending.Customer returned unused samples from product they had in stock, they can not confirm that this is the lot related to the event.Lot number for reported event will remain as unknown and returned samples will be investigated as representative samples.

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.

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 01/10/19.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.

Manufacturer Narrative

Initial investigation report attached is on representative samples, final investigation is pending.Customer returned unused samples from product they had in stock, they can not confirm that this is the lot related to the event.Lot number for reported event will remain as unknown and returned samples will be investigated as representative samples.

• 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 Key: 8345712
• MDR Text Key: 136617703
• Report Number: 8041145-2019-00002
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K071145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

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 Number: FT+152530BC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization