MAUDE Adverse Event Report: NIPRO THAILAND CORPORATION LTD NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

Model Number A357R/V844R

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Malaise (2359); Reaction (2414)

Event Date 09/17/2014

Event Type  Injury  

Event Description

After 1 1/2 hours of treatment initiation, patient experienced allergic reaction.Complained of feeling unwell, itching, shortness of breath, chest pain.Charge nurse interrupted treatment, discarded blood.Patient required antihistamine, no oxygen or further medication was necessary.Patient's treatment was then restarted on a different machine, with non-nipro branded bloodlines.No further information was provided.

Manufacturer Narrative

Manufacturer investigation result on retained samples only.Device not returned to manufacturer.

• Brand Name: NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
• Type of Device: BLOOD TUBING SET
• Manufacturer (Section D): NIPRO THAILAND CORPORATION LTD; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya 13110, th ; TH
• Manufacturer (Section G): NIPRO THAILAND CORPORATION LTD; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya 13110, th ; TH
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 4933022
• MDR Text Key: 6435706
• Report Number: 8041145-2015-00059
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: A357R/V844R
• Device Lot Number: 13F23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2013
• 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