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Model Number D-100 |
Device Problems
Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Expiration date and manufacture date are unknown.Investigation including root cause analysis is in progress.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 upon opening, there were kinks in the line, slice marks in tubing, and leaking at connection points.Two lot numbers, 4344926 and 4273794, were reported.No adverse patient effects or injury were reported by the customer.
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Manufacturer Narrative
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Other, other text: g1, and g2 email is: (b)(6), h6 - health effects codes updated.No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, icu medical will reopen this complaint for further investigation.A device history (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
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Search Alerts/Recalls
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