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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/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2021
Event Type  malfunction  
Event Description
An inventory manager reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.The sample was discarded and is not available to be returned to the manufacturer for physical evaluation.Additional information was requested, however to date has not been provided.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A lot history review was performed.There was one other complaint reported against this lot.The complaint addresses a dialyzer blood leak (no sample).A review of the production record was performed.The production record review showed there was one approved temporary dn in the production of this lot.The dn is unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.There is no recall associated with this complaint.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas (vision systems) and (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.The lot 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
An inventory manager reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.The sample was discarded and is not available to be returned to the manufacturer for physical evaluation.Additional information was requested, however to date has not been provided.
 
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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 Key12934429
MDR Text Key285481319
Report Number1713747-2021-00453
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 User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0500316E
Device Catalogue Number0500316E
Device Lot Number21KU06023
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received12/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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