MAUDE Adverse Event Report: FRESENIUS NIPRO; DIALYSIS TUBING

Lot Number A223D/V809D

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pain (1994); Urinary Retention (2119); Vomiting (2144); Reaction (2414); Sweating (2444); Ambulation Difficulties (2544)

Event Date 11/01/2015

Event Type  Injury  

Event Description

Patient has been on dialysis for 9 years.Patient has kidney cancer and had to remove 1 kidney in early 2015.In late (b)(6) 2015, the dialysis facility started using a new tube, nipro.Patient had chemical sensitivity with the tube including pain, vomiting, cns symptoms, walking difficulties and breathing difficulties.Patient had to use oxygen during and after the dialysis.Chemicals build up in the patient's body because patient cannot urinate.Patient has profuse sweating to get rid of chemicals.Pain and reactions are unbearable and getting worse after each dialysis.Patient discuss with her nephrologist, but the facility still using same tube.Patient does not want to go to the dialysis treatment because of the adverse reactions.Patient is very sick and dialysis is still ongoing with the same tube.

• Brand Name: NIPRO
• Type of Device: DIALYSIS TUBING
• Manufacturer (Section D): FRESENIUS
• MDR Report Key: 5327179
• MDR Text Key: 34421053
• Report Number: MW5058724
• Device Sequence Number: 1
• Product Code: FJK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: A223D/V809D
• Other Device ID Number: 15A23/2019-12
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 84