|
Model Number TD 100 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Information (3190)
|
Event Date 03/02/2017 |
Event Type
malfunction
|
Event Description
|
Hospital was under a boil water advisory and in their review of processes found: the td-100 is an automated reprocessor specifically for tee probes.It achieves chemical high-level disinfection.Currently there is an optional bacterial filter (0.2 micron.) hospital feels that manufacturer should ensure filters are sold with the td-100's.There shouldn't be an option to purchase without the filter.The standard for automated endoscope reprocessor's states: ansi/aami st91:2015 flexible and semi-rigid endoscope processing in health care facilities."the microbial quality of the rinse water will vary and may recontaminate the processed device (aami tir34).To avoid recontaminating the device with the rinse water, the incoming automated endoscope reprocessor (aer) water should be at least filtered using bacterial retentive filters as recommended in the aer manufacturer's written ifu." this is very similar to the tee process.
|
|
Search Alerts/Recalls
|
|
|