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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500318E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2021
Event Type  malfunction  
Event Description
A clinic manager reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.In a follow up, the manager indicated that the blood leak occurred 5 minutes into the hd treatment.Blood test strips were used and tested positive for blood.There was no observed damage to the dialyzer.The machine, a fresenius 2008h, did alarm with a blood leak alarm.The patient¿s estimated blood loss (ebl) was 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The treatment was completed with a different machine and new supplies.The complaint device was reported to be available for return to the manufacturer for evaluation.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Manufacturer Narrative
The customer returned a dialyzer from the reported lot for evaluation.The customer returned a dialyzer from the reported lot for evaluation.The sample was subjected to a laboratory bubble point leak test.The dialyzer failed; a steady stream of bubbles were coming from the cut surface at approximately 150° on the cavity id end, with the ports positioned at 0°.Upon extraction of the fiber bundle, a fiber fragment was noted from the same area as the leak.Under magnification (x20) the fiber fragment measured approximately 1.52 mm from the potting surface, an opposing end could not be isolated.There was no other damage or irregularities visually noted on the dialyzer.A review of the production record was performed.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.The investigation into the complaint was able to confirm the reported event.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 for vision systems and blood leak.
 
Event Description
A clinic manager reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.In a follow up, the manager indicated that the blood leak occurred 5 minutes into the hd treatment.Blood test strips were used and tested positive for blood.There was no observed damage to the dialyzer.The machine, a fresenius 2008h, did alarm with a blood leak alarm.The patient¿s estimated blood loss (ebl) was 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The treatment was completed with a different machine and new supplies.The complaint device was reported to be available for return to the manufacturer for evaluation.
 
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Brand Name
OPTIFLUX 180NRE 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 Key13087621
MDR Text Key286491622
Report Number1713747-2021-00478
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100156
UDI-Public00840861100156
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 Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0500318E
Device Catalogue Number0500318E
Device Lot Number21NU02017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2022
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received02/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FRESENIUS 2008H MACHINE; FRESENIUS 2008H MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
Patient Age62 YR
Patient SexMale
Patient Weight78 KG
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