MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO BLOOD TUBING SET

Model Number A068R/V728R

Device Problem Kinked (1339)

Patient Problem Hemolysis (1886)

Event Date 08/23/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing report on retained samples, actual samples never returned.

Event Description

Received two complaints from hospital reporting two patients experiencing severe hemolysis after dialysis treatment.The two incidents took place on two different dates, two different rooms with two different machines.The three common products that were used in both cases were: (b)(4) nipro gama blood set for dialysis, nipro (b)(4) elisio dialyzer high flux 190h, and (b)(4) nipro avf 16g x1" htc-15r.As a result of hemolysis, one patient felt chest pain and went through catheterization on the next day, results: coronary artreys were found to be ok.The other patient felt a stomach ache and nausea, went through a heart scan to eliminate any problems.According the both patient's physician, both patient has a very hemolytic blood.

Manufacturer Narrative

Manufacturing report on retained samples, actual samples never returned additional information: on (b)(6) 2015: per the initial reporter, the 1st patient experienced symptoms 3 1/2 hours after treatment initiation and 2nd patient experienced symptoms 30 minutes after treatment initiation, staff did not observe any kind of kink on tubing, no alarm of blood in dialysate, alarms went for high/low arterial and venous pressures.Dialysis was run at blood flow rate of 300ml/min.Both patients had routine cbc and chemistry drawn, hemolysis was found and confirmed by laboratory, they were unable to perform tests due to hemolytic serum.Tests were repeated 4 times within 24 hours.Additional confirmation was provided by an elevated ldh low haptoglobin and elevated indirect bilirubin, no significant drop in hemoglobin.Patients do not have history of allergy but do have history of high blood pressure.Not returned to manufacturer.

Event Description

Received two complaints from hospital reporting two patients experiencing severe hemolysis after dialysis treatment.The two incidents took place on two different dates, two different rooms with two different machines.The three common products that were used in both cases were: (b)(4) nipro gama blood set for dialysis, nipro (b)(4) elisio dialyzer high flux 190h, and (b)(4) nipro avf 16g x1" htc-15r.As a result of hemolysis, one patient felt chest pain and went through catheterization on the next day, results: coronary arteries were found to be ok.The other patient felt a stomach ache and nausea, went through a heart scan to eliminate any problems.According the both patient's physician, both patient has a very hemolytic blood.

• Brand Name: NIPRO BLOOD TUBING SET
• Type of Device: BLOOD TUBING SET
• 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: 5083720
• MDR Text Key: 26013902
• Report Number: 8041145-2015-00069
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: A068R/V728R
• Device Lot Number: 15B26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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): Required Intervention