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

Model Number A295R/ V806R

Device Problem Improper Flow or Infusion (2954)

Patient Problems Death (1802); Hemolysis (1886); Inflammation (1932); Ischemia (1942)

Event Date 01/15/2016

Event Type  Death  

Manufacturer Narrative

Pending final investigation on retained samples only.Actual device not returned.

Event Description

Patient suffered hemolysis at end of dialysis treatment.The physician's diagnosis of hemolysis was confirmed by the patient's blood test result.Staff noticed a kink in the dialysis tubing between the venous pump and the venous drip chamber.Dialysis machine used during treatment was gambro (baxter) ak200.Patient was sent to the hospital for further intensive care treatment.At the time of admission to the hospital, patient was diagnosed with pancreatitis.Operation was ordered at the hospital, but the patient's family refused.Patient past away ((b)(6) 2016) 4 days after admission ((b)(6) 2016) due to intestinal ischemia.(hospital refused to provide details of medical intervention at time of hospital admission and refused to provide information on type of operation ordered for the patient).

Manufacturer Narrative

Pending final investigation on retained samples only.On 4/5/2016: manufacturer final investigation attached on retained samples only, verification protocol for hemolysis test of blood tubing set and results on retained samples only attached.Actual device not returned.

Event Description

Patient suffered hemolysis at end of dialysis treatment.The physician's diagnosis of hemolysis was confirmed by the patient's blood test result.Staff noticed a kink in the dialysis tubing between the venous pump and the venous drip chamber.Dialysis machine used during treatment was gambro (baxter) ak200.Patient was sent to the hospital for further intensive care treatment.At the time of admission to the hospital, patient was diagnosed with pancreatitis.Operation was ordered at the hospital, but the patient's family refused.Patient past away ((b)(6) 2016) 4 days after admission ((b)(6) 2016) due to intestinal ischemia.(hospital refused to provide details of medical intervention at the time of hospital admission and refused to provide information on type of operation ordered for the patient).

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• 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: 5429042
• MDR Text Key: 37958731
• Report Number: 8041145-2016-00003
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: A295R/ V806R
• Device Lot Number: 14H25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2014
• 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): Death