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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 04/21/2022
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility nurse reported that an internal dialyzer blood leak occurred two minutes after the start of a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed from tube of the red hansen line and internally within the dialyzer.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.Fresenius combi set bloodlines were being utilized for the treatment.Blood test strips were used and tested positive for the presence of blood.It was also stated the blood was visually noted and the treatment was stopped immediately.No damage was identified on the dialyzer prior to use.Immediately following the event, the patient was re-setup with new supplies on a different machine where they were able to complete treatment.The patient¿s estimated blood loss (ebl) was 300 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The dialyzer was available to be returned for a manufacturer evaluation.
 
Event Description
A user facility nurse reported that an internal dialyzer blood leak occurred two minutes after the start of a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed from tube of the red hansen line and internally within the dialyzer.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.Fresenius combi set bloodlines were being utilized for the treatment.Blood test strips were used and tested positive for the presence of blood.It was also stated the blood was visually noted and the treatment was stopped immediately.No damage was identified on the dialyzer prior to use.Immediately following the event, the patient was re-setup with new supplies on a different machine where they were able to complete treatment.The patient¿s estimated blood loss (ebl) was 300 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The dialyzer was available to be returned for a manufacturer evaluation.
 
Manufacturer Narrative
Correction: h6 investigation findings.
 
Event Description
A user facility nurse reported that an internal dialyzer blood leak occurred two minutes after the start of a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed from tube of the red hansen line and internally within the dialyzer.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.Fresenius combi set bloodlines were being utilized for the treatment.Blood test strips were used and tested positive for the presence of blood.It was also stated the blood was visually noted and the treatment was stopped immediately.No damage was identified on the dialyzer prior to use.Immediately following the event, the patient was re-setup with new supplies on a different machine where they were able to complete treatment.The patient¿s estimated blood loss (ebl) was 300 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The dialyzer was available to be returned for a manufacturer evaluation.
 
Manufacturer Narrative
Additional information: d9, g1, h3 plant investigation: complaint device returned to manufacturer for physical evaluation.During visual examination of sample, a delamination was observed on cavity id end of the dialyzer extending from approximately 230° to 20°, with the dialysate ports situated at 0°.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 were two approved temporary deviation notice (dn) reported on the lot which was 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 lot met all release criteria.The investigation into the complaint was able to confirm the reported event.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 2018-0171 (vision systems) and 2018-0161 (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.
 
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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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14210458
MDR Text Key290546090
Report Number0001713747-2022-00140
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100156
UDI-Public00840861100156
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162488
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup
Report Date 06/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number22BU02005
Was Device Available for Evaluation? Device Returned to Manufacturer
Device AgeMO
Initial Date Manufacturer Received 04/21/2022
Initial Date FDA Received04/26/2022
Supplement Dates Manufacturer Received06/23/2022
06/24/2022
Supplement Dates FDA Received06/23/2022
06/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2022
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 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
Patient Age74 YR
Patient SexFemale
Patient Weight74 KG
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