Device Problem
Defective Component (2292)
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Patient Problem
Pain (1994)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the patient was at a higher medication dose but had to decrease due to bad leg and back pain.It was further reported that they have had more cassette failures with new extension sets than before.No patient injury was reported.
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Manufacturer Narrative
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Other text: h6: event problem and evaluation codes: updates not required.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.No lot number was provided; therefore, dhr (device history review) could not be performed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.
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Search Alerts/Recalls
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