Model Number 21-7302-24 |
Device Problems
Leak/Splash (1354); Gas/Air Leak (2946)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported the disposable had two leaks occurred.Second pump leak came in this week.Dislodged from the pigtail and extension set.Equashield ll-2 lot 2212817a was possibly used during this infusion.No patient injury.No additional information available.Device is returning for investigation.There were no allegations against the pumps but they will be sent in for investigation.Devices are all covered in chemo.
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Manufacturer Narrative
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One sample was returned for investigation.Visual inspection found no damages or defects to the device.Functional testing of the device occurred.No leak was detected during testing.The reported complaint is not confirmed.No root cause determined.No actions taken.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
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Search Alerts/Recalls
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