The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
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A titan one touch release pump was received for evaluation.Examination and testing of the returned components revealed the presence of surface abrasion on all pump tubing and on the detached inlet tubing.No functional abnormalities were noted with any of the returned components.The information received indicated the pump was not working, and that the physician believed that it may have been a ¿sticky pump¿, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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