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

Model Number BL+A223D/V809D

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Macular Edema (1822); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Palpitations (2467)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturer investigation report on retained samples.Device not returned to manufacturer.

Event Description

Customer complaint received on (b)(6) 2015, directly from the patient, stating she has experienced an allergic reaction, on (b)(6) 2015, during dialysis treatment while using our nipro blood tubing set.Patient apparently experienced: mental confusion, blurred vision, shortness of breath, heart palpitations, elevated blood pressure, winded(breathless), closing of throat (unable to swallow), and edema symptoms las over 2 days.Per the patient no interventions are done at the dialysis facility for these reactions.Patient takes benadryl at home but it does not alleviate the symptoms.Patient advised that she has been previously diagnosed with "chemical sensitivity syndrome," has a tendency to have type b anaphylactoid reactions to certain chemicals.History: patient has history of allergy to dialyzer, causing cns (central nervous system) difficulties, encephalopathy, patient was sent to the hospital and nephrologist ordered to change dialyzer because of the reactions.Patient states she has a couple of good treatments, then the bloodlines were changed to nipro and automatically started experiencing allergic reactions.No record of medical intervention or hospitalization.(b)(6) 2016: update received directly from patient: i was admitted to (b)(6) hospital on (b)(6) 2016 and discharged (b)(6) 2016.I was dialyzed with the nipro blood line set with not one symptom that i have been experiencing at the dialysis center.This was my first admission to the hospital since the clinic made the change.During treatment at the acute unit in the hospital using the nipro blood lines, there were no breathing problems, no mental confusion, no bilateral edema that never goes away no matter how much fluid is removed as it occurs at my home unit.No difficulty swallowing.The difficulties that i have walking after treatment at my home unit, did not duplicate itself either.Although there was a difference in the dialyzer that was changed at the unit.That problem was resolved by replacing the dialyzer.My treatment at the hospital in acutes using the nipro tubing was a totally different experience.

• 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: 5418352
• MDR Text Key: 37714369
• Report Number: 8041145-2016-00002
• 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: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: BL+A223D/V809D
• Device Lot Number: 15A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2016
• Distributor Facility Aware Date: 01/25/2016
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/08/2016
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• 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): Hospitalization