Patient reports her cassette was leaking.She said it was leaking by tubing at top of cassette.She switched to a new cassette.She did not have packaging from cassette anymore, so she did not have the lot number.No other info known.Did the reported fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? no; did we [mfr] replace the device? no; did the pt have a backup device they were able to switch to? yes; was the pt able to successfully continue their infusion? yes.Reported to (b)(6) by pt/caregiver.
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