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Model Number 21-7324-01 |
Device Problem
Failure to Infuse (2340)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported the device did not infuse and the clinician had to reset the cassette and then the infusion started.No alarm sounded to state that infusion was not running.No patient injury was reported.Additional information received via email from customer on (b)(6) 2022 and attached by icu medical in complaint: we experienced a pump recording delivery of medications yet not actually delivering the medications.When we changed the set, worked again.We suspect that there may be an issue with the sets.The pump serial number is (b)(4).The set lot numbers on site are lot 4248632 and lot 4232350.Additional information received via email from customer on (b)(6) 2022 and attached by icu medical in complaint: we have another set (lot 4232350) that seems to have a similar issue.When priming, the pump sounds like it is active but no fluid is coming out and it is recording the volume.The set was replaced on the same pump and it worked properly.Additional information received via email from customer (chief, department of anesthesiology and critical care) on (b)(6) 2022 and attached by icu medical in complaint; i am assuming it is an issue with the tubing sets themselves and i would assume we are not alone with this issue.No patient injury was reported.
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Manufacturer Narrative
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This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.One sample was returned sample was received inside of a plastic bag without its original packaging.The samples were visually inspected under normal conditions of illumination to detect conditions that could cause functional issues.No damages nor workmanship defects were detected on the sample.The sample was set for accuracy testing using a pump legacy to look for unusual function according to the procedure.No discrepancies were detected on the sample, successfully passed the test.The failure mode reported is not confirmed.Root cause cannot be determined since the complaint was not confirmed.No actions are required.
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Search Alerts/Recalls
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