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

Model Number BL+A368R/V854R

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem Death (1802)

Event Date 03/28/2017

Event Type  Death  

Event Description

After 35 minutes of initiating dialysis treatment with a blood flow rate of 350ml/min, ultra filtration maxof 700ml/h, in a chronic dialysis facility, disconnection occurred between the venous bloodline and the patient's catheter(canaud catheter).Blood leaked and less than 1 liter of blood was lost.The patient was not responding, staff began medical intervention, attempted resuscitation and intubation for 20 minutes, non-stop, without success.Patient passed away.Last vitals taken; blood pressure: 131/64, pulse: 89, venous pressure: 131, arterial pressure: 116.

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOODLINE
• 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 107 avenue; miami 33172 ; 3055997174
• MDR Report Key: 6531514
• MDR Text Key: 73984661
• Report Number: 8041145-2017-00006
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/27/2017

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 Expiration Date: 09/30/2021
• Device Model Number: BL+A368R/V854R
• Device Lot Number: 16J26
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 72