MAUDE Adverse Event Report: FRESENIUS USA MANUFACTURING, INC. OPTIFLUX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Lot Number 24AU06008

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Urticaria (2278)

Event Date 03/01/2024

Event Type  Injury  

Event Description

Patient arrived today reporting that she had a rash over her chest, abdomen, and back which started on wednesday night after her first dialysis treatment.Patient describes it as hot, itchy, red, with hives.She did not go to emergency department (ed) that night thinking it would get better, took benadryl and ibuprofen and her daughter applied a tea compress all over her rash.She reports her primary care physician looked at it yesterday as she had an appt with them already scheduled and thought it looked like contact dermatitis, but at that point the symptoms had been relieved and patient was feeling better.This registered nurse asked if she had changed any laundry detergents, started any new meds used any new products such as lotions etc.Patient denies having changed anything in her daily routine besides having dialysis.This registered nurse called dr.(b)(6) after learning this information and reported all the information.It was decided that it did not present like a typical dialyzer reaction and that we would proceed with treatment, extra cautious and paying close attention to patient in the beginning because md reports if it was reaction, it could be worse and come on sooner the next time she was exposed.Patient was agreeable.Used betadine instead of chlorhexidine on the dressing to rule out a reaction to that.Benadryl was predrawn, o2 machine next to chair and other emergency meds were on hand at the start of treatment.Clinic policy and procedure was reviewed for what to do if suspected dialyzer reaction or other reaction occurred.

• Brand Name: OPTIFLUX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS USA MANUFACTURING, INC.
• MDR Report Key: 18857212
• MDR Text Key: 337348041
• Report Number: MW5152447
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/04/2024

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 Lot Number: 24AU06008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White