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 Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2022 |
Event Type
malfunction
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Event Description
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A user facility registered nurse (rn) reported that a blood leak occurred during on (b)(6) 2022 immediately after the start of the patient¿s hemodialysis (hd) treatment.The rn confirmed that the machine, a fresenius 2008t machine, alarmed appropriately with a "minor" blood leak alarm.Blood leak test strips were not used as blood was visually observed within the dialyzer housing and along the arterial line.The rn also stated that fresenius bloodlines were used for treatment and confirmed that the leak was internal and no external blood leak was observed.The rn stated that there were no defects or damage seen on the dialyzer.Per rn the patient¿s blood was not returned and stated the estimated blood loss was 10cc.Immediately following the event, the patient was re-setup with new supplies on a different machine where the patient was able to complete treatment.The rn confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The dialyzer was available to be returned for manufacturer evaluation.
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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Manufacturer Narrative
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Plant investigation: the reported complaint was not confirmed as the complaint device was not returned to date 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 nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.During the lot history review it was noted that there were two other complaints reported against the lot.One complaint is not associated with the current event.The other complaint addresses an internal blood leak (no sample).A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.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 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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Event Description
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A user facility registered nurse (rn) reported that a blood leak occurred during on (b)(6)2022 immediately after the start of the patient¿s hemodialysis (hd) treatment.The rn confirmed that the machine, a fresenius 2008t machine, alarmed appropriately with a "minor" blood leak alarm.Blood leak test strips were not used as blood was visually observed within the dialyzer housing and along the arterial line.The rn also stated that fresenius bloodlines were used for treatment and confirmed that the leak was internal and no external blood leak was observed.The rn stated that there were no defects or damage seen on the dialyzer.Per rn the patient¿s blood was not returned and stated the estimated blood loss was 10cc.Immediately following the event, the patient was re-setup with new supplies on a different machine where the patient was able to complete treatment.The rn confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The dialyzer was available to be returned for manufacturer evaluation.
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Search Alerts/Recalls
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