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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500316E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Itching Sensation (1943)
Event Date 09/01/2021
Event Type  Injury  
Event Description
A patient contacted the fresenius compliance hotline and complained of itchy skin when using a fresenius dialyzer.Additional follow-up was conducted with a hemodialysis (hd) nurse familiar with the patient.The nurse stated the patient did not experience any serious adverse effects from use of the optiflux 160nre dialyzer.It was reported that the patient has pre-existing allergies and sensitive skin which is aggravated by anxiety.Per the nurse, the patient takes over the counter zyrtec at home.Additionally, it was stated the patient had been having ongoing itching at the hemodialysis catheter site, allegedly caused by low quality adhesive bandages (not a fresenius product) used to protect the site.Per the nurse, in (b)(6) 2021 (exact date unknown), the patient had their hemodialysis treatment via a fresenius optiflux 160nre dialyzer for hemodialysis per physician order.It was stated the patient complained of generalized itching during dialysis with the optiflux 160nre dialyzer.The nurse indicated the event did not result in any medical intervention and was managed with the patients over the counter zyrtec.Reportedly, the patient was able to complete the treatment without any adverse effects.Subsequently, the patient was changed to a fresenius optiflux 180nr dialyzer which gets rinsed with a bag of saline before each hd treatment.No further incidents of itching was reported.Additionally, the patient was ordered a special tegaderm bandage (not a fresenius product) for their hd catheter site, according to the nurse.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: an association exists between hd treatment utilizing the fresenius optiflux 160nre dialyzer and the patient¿s symptoms of itching.However, there is no objective evidence that the patient¿s itching was related to a malfunction or product issue with the fresenius optiflux 160nre dialyzer.Dialyzer reactions are a well-documented potential complication during hemodialysis.The patient had a reported medical history that is significant for pre-existing allergies, sensitive skin (with itch at the hemodialysis site) and anxiety (which worsens itch).While the patient complained of itching, the event was managed with the patients over the counter zyrtec and the patient completed the hemodialysis treatment without any further event(s).The patient has since resumed hemodialysis using another fresenius dialyzer without further reported issue.
 
Manufacturer Narrative
Additional information: g1 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided for this complaint, a search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Six lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on two of the lots which were unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lots met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
 
Event Description
A patient contacted the fresenius compliance hotline and complained of itchy skin when using a fresenius dialyzer.Additional follow-up was conducted with a hemodialysis (hd) nurse familiar with the patient.The nurse stated the patient did not experience any serious adverse effects from use of the optiflux 160nre dialyzer.It was reported that the patient has pre-existing allergies and sensitive skin which is aggravated by anxiety.Per the nurse, the patient takes over the counter zyrtec at home.Additionally, it was stated the patient had been having ongoing itching at the hemodialysis catheter site, allegedly caused by low quality adhesive bandages (not a fresenius product) used to protect the site.Per the nurse, in (b)(6) 2021 (exact date unknown), the patient had their hemodialysis treatment via a fresenius optiflux 160nre dialyzer for hemodialysis per physician order.It was stated the patient complained of generalized itching during dialysis with the optiflux 160nre dialyzer.The nurse indicated the event did not result in any medical intervention and was managed with the patients over the counter zyrtec.Reportedly, the patient was able to complete the treatment without any adverse effects.Subsequently, the patient was changed to a fresenius optiflux 180nr dialyzer which gets rinsed with a bag of saline before each hd treatment.No further incidents of itching was reported.Additionally, the patient was ordered a special tegaderm bandage (not a fresenius product) for their hd catheter site, according to the nurse.
 
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Brand Name
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key12724245
MDR Text Key282343164
Report Number1713747-2021-00407
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100149
UDI-Public00840861100149
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number0500316E
Device Catalogue Number0500316E
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received12/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
Patient SexFemale
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