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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500318N
Device Problem Fluid/Blood Leak (1250)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
A user facility reported that a dialyzer blood leak occurred about 12 minutes into the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was not visually observed and there was no defect or damage noted on the dialyzer.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient did not complete treatment due to an issue with their access needle (non-fresenius device), however, it was confirmed that the patient has been continuing hd treatments without issue.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation and was subject to a laboratory bubble point test.The dialyzer passed testing (possibly due to coagulated blood).The dialyzer was then disassembled for further evaluation.A fiber fragment was identified at approximately 0° on the non-cavity id end.Under magnification (x20), the identified potted fiber fragment measured approximately 0.28mm in length.The opposing end of the fiber could not be isolated.No other damage or irregularities were noted on the returned sample.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.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 lot met all release criteria.The investigation into the complaint was able to confirm the reported event.
 
Event Description
A user facility reported that a dialyzer blood leak occurred about 12 minutes into the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was not visually observed and there was no defect or damage noted on the dialyzer.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient did not complete treatment due to an issue with their access needle (non-fresenius device), however, it was confirmed that the patient has been continuing hd treatments without issue.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
 
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Brand Name
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
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
MDR Report Key11051480
MDR Text Key224312342
Report Number1713747-2020-00527
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100125
UDI-Public00840861100125
Combination Product (y/n)N
PMA/PMN Number
K002277
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2022
Device Model Number0500318N
Device Catalogue Number0500318N
Device Lot Number19DU04022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2020
Device AgeMO
Date Manufacturer Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
Patient Age74 YR
Patient Weight90
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