(b)(4) was notified by facility that at the end of a procedure the amount of fluid dispensed by the manager system (displayed 1600mls) was different than the fluid amount manually calculated by the staff (3000mls).Due to the excessive amount of fluid dispensed patient received a foley catheter, stayed in the pacu for longer than normal and most likely required an overnight admission for fluid output management.Two devices work together as one system: id# 2222.011 - irrigation pump - mdr 1418479-2017-00010 id# 2223.011 - scale/stand - mdr 1418479-2017-00011.(b)(4) received system on 03/17/2008.Facility purchased system on 09/02/2008.System sent to (b)(4) for repaired/calibrated on 05/10/2011.No similar issues reported in the last three years.Request for additional/missing information has been sent to user facility, no response as of 22jun2017.System (pump and scale) received by (b)(4) and will be sent to manufacturer (world of medicine (w.O.M.) (b)(4)) for investigation.(b)(4) considers this matter closed.However, in the event (b)(4) receives any additional information, (b)(4) will provide manufacturer of the devices (w.O.M.) with follow-up information.
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(b)(4) received investigation results from world of medicine germany (wom gmbh) (manufacturer) on 22sep2017, device evaluation below.Wom indicated pump showed heavy signs of wear and tear.Paint had been damaged, screws on bottom were oxidized, pump head and roller wheel showed several points of impact and saline residue found inside device near pressure sensor.Wom performed device history review and found no discrepancies.Wom performed complaint history review and no similar complaint were reported between jul 2006 and aug 2017.Wom indicated device worked according to specification in regards to the deficit measurement, report event could not be confirmed.Wom indicated the most probable cause appeared to be that the deficit had been reset to zero after the fluid bag was changed during the procedure.Wom indicated that according to sticker on the device, it was due for service/calibration apr 2013.(b)(4) contacted user facility on four different occasions, once via phone call and three times via emails, in an effort to gather additional/missing report information.No response received as of 10/02/2017.(b)(4) considers this matter closed.However, in the event (b)(4) receives any additional information, (b)(4) will provide fda with follow-up report.
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