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 04/25/2022 |
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 external dialyzer blood leak occurred six minutes after the start of a patient¿s hemodialysis (hd) treatment.The nursing staff was able to detect the leak and was observed from the venous head of the dialyzer.The machine, a fresenius 4008s, did not alarm with a blood leak alert and blood test strips were not used.Non-fresenius bloodlines were being utilized for the treatment.No damage was identified on the dialyzer prior to use.Immediately following the event, the patient was re-setup with new supplies on the same machine where they were able to complete treatment.The patient¿s estimated blood loss (ebl) was 100 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 not available to be returned for a manufacturer evaluation as it was reportedly discarded.
|
|
Event Description
|
A user facility nurse reported that an external dialyzer blood leak occurred six minutes after the start of a patient¿s hemodialysis (hd) treatment.The nursing staff was able to detect the leak and was observed from the venous head of the dialyzer.The machine, a fresenius 4008s, did not alarm with a blood leak alert and blood test strips were not used.Non-fresenius bloodlines were being utilized for the treatment.No damage was identified on the dialyzer prior to use.Immediately following the event, the patient was re-setup with new supplies on the same machine where they were able to complete treatment.The patient¿s estimated blood loss (ebl) was 100 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 not available to be returned for a manufacturer evaluation as it was reportedly discarded.
|
|
Manufacturer Narrative
|
Plant investigation: reported complaint was not confirmed as complaint device was not returned for manufacturer evaluation.During lot history review it was noted there were two other complaints reported against lot.One complaint addresses an external prime leak that was confirmed to be a damaged port with sample investigation.Second complaint addresses an internal blood leak (no sample).These are unrelated to current event.Review of production record was performed.There was no indication of product non-acceptance or deviation in manufacturing process related to complaint event, including non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to complaint.Reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during manufacturing process which could be associated with the reported event.Lot met all release criteria.A definitive conclusion regarding complaint incident cannot be reached without physical examination of actual device.Therefore, complaint is not confirmed.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.The blood leak was external and observed from the venous head cap, and there was no other specific details regarding a cause, the complaint will be coded 622 - undefined header leak.
|
|
Search Alerts/Recalls
|
|
|