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Catalog Number 21-7002-24 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other text: no product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.No lot number was provided.Therefore, a history record review could not be conducted.D4: lot number, expiration date and h4 are unknown.
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Event Description
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It was reported that the pump finished five hours early.No patient injury was reported.
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Manufacturer Narrative
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Other, other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.D3, g1,2 email is: regulatory.Responses@icumed.Com, corrected data: previously reported statement regarding device history review was incorrect and has been updated in h10.
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Search Alerts/Recalls
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