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Model Number 21-7091-24 |
Device Problem
Inaccurate Delivery (2339)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2023 |
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 that the product was under infusing, does not pass accuracy test; it is uncertain of the cause.No patient involvement reported.
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Manufacturer Narrative
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Test details and photo attached to complaint.The device was indeed tested with the admin sets provided.The users had noticed that after infusion too much fluid was left in the bag.This indicated possible under-infusion and the device (complete with admin set) was handed over for investigation.They were tested for delivery accuracy and found that it was slightly out of tolerance, delivering a little less than it should.This could be caused by an issue with giving sets (not so likely the pump) and requested that device and giving sets be sent in for investigation.It is not likely there is any problem with the device.However, it is possible that the admin sets are not within tolerance.This is what needs to be determined.
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Manufacturer Narrative
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Other, other text: one disposable was received for evaluation.Visual inspection found sticky stains on the tubing sections, no other damage or defects were observed.Functional testing was conducted.Upon review, the reported problem was unable to confirm or duplicate the reported problem.No serial number was provided; therefore, a device history record (dhr) review could not be conducted.D3, g1,g2 email is: regulatory.Responses@icumed.Com.
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Search Alerts/Recalls
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