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, 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 patient line which resulted in leak, which is known to cause this alarm.The cause of the leak could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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