MAUDE Adverse Event Report: NIPRO (THAILAND) CORP., LTD. NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR; BLOODLINES

Model Number A347TR/V719TR

Device Problems Kinked (1339); Leak/Splash (1354)

Patient Problems Chest Pain (1776); Hemolysis (1886); Chills (2191)

Event Date 07/16/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation conclusion pending.

Event Description

After 2 hours into dialysis treatment, patient complained about loss of appetite and feeling cold.Treatment interrupted, took pv/pa, results 90/67.Patient was connected again to dialysis treatment using same equipment.Patient started complaining of chest pain and tiredness.Treatment was interrupted again, tension >20, ecg performed and was normal.Hemolysis was confirmed: ldh 3671 ui/i; cpk 270ui/i.Patient connected second time with new bloodlines (same code & lot) and new dialyzer.Blood leakage was noticed and confirmed with test strip.Treatment interrupted again.New system was set up using new machine, new bloodline (same code and lot#), and new dialyzer, patient connected to dialysis for the third time.Blood leak was detected again.Patient was prescribed cortisone ivd et a'erosol.No further information was provided.Patient was returned home no further complications only feeling of tiredness.

Manufacturer Narrative

Evaluation conclusion pending: 11/21/2016: corrections made to details of complaint submitted; one patient, same date of occurrence ((b)(6) 2016), 3 separate incidents: first incident: kink in tubing noticed after 2 hours into treatment, treatment interrupted.Second incident: after 2 hours into treatment, patient started complaining of loss of appetite and feeling cold, treatment interrupted again, took pv/pa, results 90/67.Patient was connected to dialysis treatment using same equipment.Patient started complaining of chest pain and tiredness.Treatment was interrupted again, tension >20, ecg performed and was normal.Hemolysis was confirmed: ldh 3671 ui/i; cpk 270 ui/i.New system with new dialyzer was set up.Patient connected again.Third incident: blood leakage was noticed and confirmed with test strip.Treatment was interrupted.New system was set up using new machine, new bloodlines (same lcode and lot number), and new dialyzer, patient connected to dialysis for the 4th time, and bloodleak was detected once again, patient was prescribed cortisone ivd et a'rosol.No further information was provided.Patient was returned home no further complications, only feeling of tiredness.

Event Description

After 2 hours into dialysis treatment, patient complained about loss of appetite and feeling cold.Treatment interrupted, took pv/pa, results 90/67.Patient was connected again to dialysis treatment using same equipment.Patient started complaining of chest pain and tiredness.Treatment was interrupted again, tension >20, ecg performed and was normal.Hemolysis was confirmed: ldh 3671 ui/i; cpk 270ui/i.Patient connected second time with new bloodlines (same code and lot) and new dialyzer.Blood leakage was noticed and confirmed with test strip.Treatment interrupted again.New system was set up using new machine, new bloodline (same code and lot number), and new dialyzer, patient connected to dialysis for the third time.Blood leak was detected again.Patient was prescribed cortisone ivd et a'erosol.No further information was provided.Patient was returned home no further complications only feeling of tiredness.

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOODLINES
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 6081174
• MDR Text Key: 59352439
• Report Number: 8041145-2016-00021
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: A347TR/V719TR
• Device Lot Number: 16B13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other