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

Model Number A372R-V858R-GT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Shock (2072)

Event Date 12/04/2018

Event Type  Injury  

Event Description

After completion of dialysis treatment, patient went into severe shock.Patient was given fluids and the blood was returned.Patient was stabilized and sent to the er for observation.Blood tests were performed and patient had low sodium levels.Patient recovered and was discharged.Patient returned to scheduled dialysis treatment at the dialysis unit without further complications.Preliminary inquiry shows that during the event the dialysis machine was immediately checked by a qualified technician who found no evidence of any fault.Customer did not record the lot number involved in the incident.They have two different possible lot numbers: lot# 18a10.Manufactured: 01/10/18.Expiration: 12/31/22.Lot# 18h27.Manufactured: 08/27/18.Expiration: 07/31/23.

Manufacturer Narrative

This report is being submitted retrospectively per fda request.

Manufacturer Narrative

Investigation still in progress.(b)(6) 2018: correction made to section h6 device code.Changed from 1023 to 2993.Added possible lot numbers with manufacturing date and expiration date in section b5.(b)(6) 2019: investigation attached is on retained samples only, customer did not return the actual used device.

Event Description

After completion of dialysis treatment, patient went into severe shock.Patient was given fluids and the blood was returned.Patient was stablized and sent to the er for observation.Blood tests were performed and patient had low sodium levels.Patient recovered and was discharged.Patient returned to scheduled dialysis treatment at the dialysis unit without further complications.Preliminary inquiry shows that during the event the dialysis machine was immediately checked by a qualified technician who found no evidence of any fault.Customer did not record the lot number involved in the incident.They have two different possible lot numbers: lot# 18a10 manufactured: (b)(6) 2018.Expiration: 12/31/22.Lot# 18h27 manufactured: (b)(6) 2018.Expiration: 07/31/23.

• 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; bangnomko,; ayuthaya, , 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; bangnomko,; ayuthaya, , 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 8200784
• MDR Text Key: 314671016
• Report Number: 8041145-2018-00020
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A372R-V858R-GT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization