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Lot Number 4220001 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Solicited: pt reports experiencing a cassette issue from lot number 4220001 pt stated cassette was giving a non-disposable alert with each pump.Changing cassettes corrected the issue.Did the reported product fault occur while in use with a pt? yes.Did the product issue cause or contribute to pt or clinical injury? no; is the cassette available to be returned for investigation? yes, if pt holds on to it describe in detail any, and all damage to the cassette: giving non-disposable alert despite using both pumps.Pt switched to a new cassette and alert stopped; has this incident happened within the past 6 months? yes.Has this pt reported a pump malfunction within the past 6 months? yes.Life sustaining infusion.Pt able to continue infusion with new cassette.What is the outcome of the event? resolved.No further information available.Reported to (b)(6) by pt/caregiver.
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Event Description
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Solicited: pt reports experiencing a cassette issue from lot number 4220001 pt stated cassette was giving a non-disposable alert with each pump.Changing cassettes corrected the issue.Did the reported product fault occur while in use with a pt? yes.Did the product issue cause or contribute to pt or clinical injury? no; is the cassette available to be returned for investigation? yes, if pt holds on to it describe in detail any, and all damage to the cassette: giving non-disposable alert despite using both pumps.Pt switched to a new cassette and alert stopped; has this incident happened within the past 6 months? yes.Has this pt reported a pump malfunction within the past 6 months? yes.Life sustaining infusion.Pt able to continue infusion with new cassette.What is the outcome of the event? resolved.No further information available.Reported to (b)(6) by pt/caregiver.
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Search Alerts/Recalls
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