G1 manufacturing facility - this device was manufactured at one of the two following manufacturing sites: baxter healthcare - mountain home 1900 n highway 201 mountain home, ar 72653, united states.Baxter healthcare - carretera sanchez km 18.5, parque industrial itabo, piisa haina, san cristobal 91000, dominican republic.An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, a disconnection was reported between the extension line and the patient line of the homechoice cassette which resulted in a leak, which is known to cause this alarm.The cause of the disconnection could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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