Additional information: h3 plant investigation: eight blood pump rotors were returned to the manufacturer under the return goods authorization (rga) number assigned to this case file.None of the returned rotors are identified as belonging to a specific complaint or machine serial number.The evaluation of all eight samples has been captured within this investigation.During a visual inspection it was noted that five samples had loose and deformed sleeves over their guide pins, two samples were missing sleeves, and one sample had a damaged sleeve.The samples were tested with a bloodline and water on a blood pump module of a test machine at a rate of 450 ml/min.None of the rotors damaged the bloodline and no leaks occurred.The sleeve remained intact and no further damage was done to the rotor during testing.The reported fluid leaks could not be confirmed as they could not be duplicated during testing.However the reported physical damage has been confirmed.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were two approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.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.The investigation into the complaint was able to confirm the reported event.
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