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

Model Number A347TR/V719TR

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hyperthermia (1909)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

3:30 hours into dialysis treatment, staff found blood leaking between t connector and tubing, right below the bvs (blood volume sensor).Patient lost about 10-15ml of blood.Machine did not alarm.Patient completed dialysis treatment.Patient then encountered hyperthermia and thrombocytopenia.Patient was sent to a dispensary to receive antibiotic treatment to treat hyperthermia.Patient recovered after treatment.Sample was discarded.Other devices used: dialysis machine: gambro ak200, avf needle: avsf1520-htc-30rgt.

• 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,?, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,?, 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 8765383
• MDR Text Key: 166969684
• Report Number: 8041145-2019-00006
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: A347TR/V719TR
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 18G21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2018
• 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; Required Intervention