OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 0500318E |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
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Event Description
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A user facility inventory manager reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.The facility administrator (fa) confirmed during follow-up that the blood leak occurred immediately after the initiation of treatment.The blood leak was noted as being an internal blood leak that was visually observed at the hansen connector.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood.There was no defect of damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 200 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
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Manufacturer Narrative
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Additional information: d10, h3 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.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 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 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.
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Manufacturer Narrative
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Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the visual examination of the sample, a delamination was observed on the cavity id end of the dialyzer extending from approximately 140 degrees to 190 degrees with the dialysate ports situated at 0°.No other damage or irregularities were noted on the returned sample.The investigation into the complaint was able to confirm the reported event.
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