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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 Fluid Leak (1250)
Patient Problem Itching Sensation (1943)
Event Date 02/08/2021
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: a temporal relationship exists between a blood leak occurring with the fresenius optiflux 160nre dialyzer during this patient¿s hd treatment and subsequent blood loss (approximately 250cc) with associated itching which was resolved via treatment with intravenous (iv) benadryl on an outpatient basis. However, a causal relationship could not be determined. The patient was able to complete their regularly scheduled hd treatment without any further adverse events/hospitalization. The optiflux dialyzer manufacturer instructions for use cautions that blood leaks can occur during treatment which can lead to patient blood loss. Therefore, a causal/contributory relation cannot be excluded. Currently, there is no allegation of any visual defects or product deficiency with the fresenius optiflux 160nre dialyzer that led to the reported blood leak. Reportedly, the patient has since continued their regularly scheduled hd therapy with the same brand dialyzer without any further issues or complaints of itching.
 
Event Description
A user facility biomedical technician (biomed) reported to fresenius customer service that a dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment and that the patient complained of itching. Additional information was obtained through follow-up with the facility¿s clinical manager (cm). The dialyzer used for the treatment was reportedly primed, per clinic protocol. There were no visual defects noted on the device prior to use. After treatment began (time not specified), the dialysis machine alarmed with a blood leak alert and blood was visible in the dialysate line (as expected). The patient¿s hd treatment was discontinued temporarily. The patient¿s blood was not rinsed back, per clinic protocol. Therefore, the patient lost approximately 250 cc of blood. The patient¿s vitals remained normal and the patient did not have any serious injuries due to the reported blood loss. However, the patient did complain of itching near the scapula area, stomach, and legs post-incident. As a result, the patient¿s nephrologist ordered benadryl intravenously which resolved the patient¿s itch. The patient completed their treatment with a new dialysis set up, without any harm incurred. The patient did not require hospitalization. The patient has continued their regularly scheduled hd therapy with the same brand dialyzer without any further issues or complaints (including itching). The dialyzer was reported to be available for manufacturer evaluation.
 
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Brand NameOPTIFLUX 160NRE DIALYZER FINISHED ASSY.
Type of DeviceDIALYZER, 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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11380691
MDR Text Key243127320
Report Number1713747-2021-00056
Device Sequence Number1
Product Code KDI
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 user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0500316E
Device Catalogue Number0500316E
Device Lot Number20NU06021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received03/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2021 Patient Sequence Number: 1
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