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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 Problems Fire (1245); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/17/2021
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 biomedical technician reported that an internal dialyzer blood leak occurred during a patients hemodialysis (hd) treatment.Upon follow up with a nurse at the user facility, it was reported that the blood leak occurred immediately after initiation of the hemodialysis treatment the blood leak was visually observed in the top of venous side of the dialyzer.The unspecified fresenius hemodialysis machine alarmed appropriately with a blood leak alert.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were used for the treatment.There was no reported damage identified on the dialyzer.After the machine alarmed, treatment was halted; it was unknown if the patients blood was returned.There were no reported blood loss.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 patient was able to complete treatment after being set up with new supplies on the same machine.It was unspecified if the dialyzer was available to be returned for evaluation.Photos were provided for evaluation.
 
Event Description
A user facility biomedical technician reported that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.Upon follow up with a nurse at the user facility, it was reported that the blood leak occurred immediately after initiation of the hemodialysis treatment the blood leak was visually observed in the top of venous side of the dialyzer.The unspecified fresenius hemodialysis machine alarmed appropriately with a blood leak alert.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were used for the treatment.There was no reported damage identified on the dialyzer.After the machine alarmed, treatment was halted; it was unknown if the patient¿s blood was returned.There were no reported blood loss.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 patient was able to complete treatment after being set up with new supplies on the same machine.It was unspecified if the dialyzer was available to be returned for evaluation.Photos were provided for evaluation.
 
Manufacturer Narrative
Additional information: a4 correction: d5, g2 health professional changed from "yes" to "no", g2 company representative changed from "no" to "yes", h6 medical device problem code.
 
Event Description
A user facility biomedical technician reported that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.Upon follow up with a nurse at the user facility, it was reported that the blood leak occurred immediately after initiation of the hemodialysis treatment the blood leak was visually observed in the top of venous side of the dialyzer.The unspecified fresenius hemodialysis machine alarmed appropriately with a blood leak alert.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were used for the treatment.There was no reported damage identified on the dialyzer.After the machine alarmed, treatment was halted; it was unknown if the patient¿s blood was returned.There were no reported blood loss.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 patient was able to complete treatment after being set up with new supplies on the same machine.It was unspecified if the dialyzer was available to be returned for evaluation.Photos were provided for evaluation.
 
Manufacturer Narrative
Correction: h6 medical device problem code.
 
Event Description
A user facility biomedical technician reported that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.Upon follow up with a nurse at the user facility, it was reported that the blood leak occurred immediately after initiation of the hemodialysis treatment the blood leak was visually observed in the top of venous side of the dialyzer.The unspecified fresenius hemodialysis machine alarmed appropriately with a blood leak alert.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were used for the treatment.There was no reported damage identified on the dialyzer.After the machine alarmed, treatment was halted; it was unknown if the patient¿s blood was returned.There were no reported blood loss.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 patient was able to complete treatment after being set up with new supplies on the same machine.It was unspecified if the dialyzer was available to be returned for evaluation.Photos were provided for evaluation.
 
Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.There were two photos provided.The photo show a magnified view of the product label of the dialyzer in a bag.The second photo shows the dialyzer in a bag with blood throughout the dialyzer.No irregularity is visible in the photos.During the lot history review it was noted that there was one other complaint reported against the lot.The complaint addresses an internal blood leak (no 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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.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 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
MDR Report Key12268259
MDR Text Key264781845
Report Number1713747-2021-00248
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100149
UDI-Public00840861100149
Combination Product (y/n)N
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0500316E
Device Catalogue Number0500316E
Device Lot Number21DU01013
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received08/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE
Patient Age81 YR
Patient Weight84
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