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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 10/05/2022
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 nurse reported that there was a blood leak during a hemodialysis (hd) treatment.The machine alarmed at the start of treatment and a blood leak was seen in the header and in the dialysate effluent.In a follow up, the manager clarified that the blood leak occurred within first six minutes after starting the hd treatment.The blood leak was described as being an internal blood leak.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used.The leak was visually seen in the header of the dialyzer.Fresenius bloodlines were used.There was an internal crack seen within the header of the dialyzer.The patient¿s estimated blood loss (ebl) was 300ml - 350 ml.There was no patient injury, adverse events or medical intervention required as a result of this event.The treatment was completed the same day with new supplies on the same machine.The device is available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.Although it was indicated the complaint device is available, no sample has been provided for evaluation.According to the third party carrier's website, the provided shipping materials were sent to the customer and subsequently received.In the event a sample is returned for evaluation at a later date, the complaint file will be updated accordingly.The reported complaint could not be confirmed, as a definitive conclusion regarding the complaint incident cannot be reached based on the limited information provided.A review of the production record was performed.The production record review showed there was one unrelated approved temporary deviation notice in the production of this lot.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.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 reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.
 
Event Description
A nurse reported that there was a blood leak during a hemodialysis (hd) treatment.The machine alarmed at the start of treatment and a blood leak was seen in the header and in the dialysate effluent.In a follow up, the manager clarified that the blood leak occurred within first six minutes after starting the hd treatment.The blood leak was described as being an internal blood leak.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used.The leak was visually seen in the header of the dialyzer.Fresenius bloodlines were used.There was an internal crack seen within the header of the dialyzer.The patient¿s estimated blood loss (ebl) was 300ml - 350 ml.There was no patient injury, adverse events or medical intervention required as a result of this event.The treatment was completed the same day with new supplies on the same machine.The device is available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
Corrected information: d.4.
 
Event Description
A nurse reported that there was a blood leak during a hemodialysis (hd) treatment.The machine alarmed at the start of treatment and a blood leak was seen in the header and in the dialysate effluent.In a follow up, the manager clarified that the blood leak occurred within first six minutes after starting the hd treatment.The blood leak was described as being an internal blood leak.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used.The leak was visually seen in the header of the dialyzer.Fresenius bloodlines were used.There was an internal crack seen within the header of the dialyzer.The patient¿s estimated blood loss (ebl) was 300ml - 350 ml.There was no patient injury, adverse events or medical intervention required as a result of this event.The treatment was completed the same day with new supplies on the same machine.The device is available to be returned to the manufacturer for evaluation.
 
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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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key15633095
MDR Text Key306908244
Report Number0001713747-2022-00434
Device Sequence Number1
Product Code KDI
UDI-Device Identifier10840861100146
UDI-Public00840861100149
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,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 12/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2022
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 Number22KU06019
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received11/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2022
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 Age34 YR
Patient SexFemale
Patient Weight43 KG
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