SMITHS MEDICAL ASD, INC. MEDEX PRESSURE INFUSION C-FUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS
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Model Number MX4805 |
Device Problems
Inflation Problem (1310); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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One unit received for investigation and was clean in appearance with no markings.Unit received with cracking evident in the stopcock ports along with cracking in the luer lock that attached to the c port of the stopcock.Functional: unit was manually pumped up by using the bulb assembly attached to approximately 400mmhg and allowed to set to observe for leaks, the assembly was observed to have a slow leak and confirmed to be leaking through the cracking on the stopcock ports.Unable to determine root cause for cracking as found although cracking is typical with stress caused by excess tightening or chemical attack.Unable to perform device history record review as no product with this lot number remained in inventory for additional inspection.510(k) exempt this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Event Description
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It was reported that the bag will inflate, however does not retain pressure, empties gradually.No patient injury was reported.
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Search Alerts/Recalls
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