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 - dominican republic.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 hole in the supply line of the homechoice cassette was reported, which is known to cause this alarm.The cause of the hole in the supply line of the homechoice cassette could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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