MAUDE Adverse Event Report: FRESENIUS HEMODIALYZER, RE-USE, HIGH FLUX

Lot Number 5M1546

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

Patient Problems Dyspnea (1816); Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Event Description

This complaint originated as a result of the baxter clinical help line contacting corporate product surveillance voice mail on 11-10-10 to relay a report received from a doctor in reference to a ct 190g dialyzer (product code - 5m1546) that a patient developed hives and heavy breathing after hemodialysis treatment.The doctor requested to speak to a medical specialist about this problem.No other informaiton was available.On 11-17-10, product surveillance placed a call to the doctor.He stated that he is the patient's allergist doctor.The patient goes to davita dialysis center 3 times a week for hemodialysis treatment.The patient uses the ct-190 re-use dialyzers.The patient has experienced hives, itching and shortness of breath at times during the dialysis therapy.The patient was taking heparin during the dialysis, but has recently stopped using the heparin which has eased up the symptoms a little.The patient has been having these reactions for about a year now.The patient has been using benadryl beforehand, which helps a bit.The patient takes metoprolo medication and recently started taking epogen medication.The patient has chronic lung problems.The doctor did not have any information regarding the hemodialysis treatment or dialyzer.The doctor provided the dialysis clinic's phone number and the name of the patient.This writer gave him the clinician renal helpline number.Patient injury reported: yes medical intervention required: yes.On 11-17-10, product surveillance placed a call to the davita clinic and talked to the nurse regarding this patient with the reaction.She stated that the patient had just started with their clinic in the middle of (b)(6) 2010.The patient was going to a different clinic (b)(6) that used fresenius dialyzers and the patient was using heparin during the treatment.The patient was having the allergic reaction at the fresenius clinic.The fresenius clinic sent the patient to the davita clinic.Davita started the patient on the baxter ct 190 dialyzers without heparin.The patient no longer has the allergic reactions.There is no allegation against the baxter ct 190 dialyzer.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: HEMODIALYZER, RE-USE, HIGH FLUX
• Type of Device: HEMODIALYZER, RE-USE, HIGH FLUX
• Manufacturer (Section D): FRESENIUS
• MDR Report Key: 17528196
• MDR Text Key: 321142974
• Report Number: MW5135127
• Device Sequence Number: 1
• Product Code: MSF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 5M1546
• Patient Sequence Number: 1