The device was received for evaluation without a pouch.A visual inspection was performed with the naked eye which noted that the heater bag line (tubing) was separated from the welded cassette sub-assembly.There was solvent residue present in the tubing and the deformed tubing shape showed the tubing had been inserted fully into the port during the manufacturing process.An underwater pressure test was performed with no issues noted.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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