Catalog Number 21-2111-0100-51 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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D5 is unknown.No information has been provided to date.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 the cassette assembly was defective.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).Please disregard the initial report submitted with the mfr number: 3012307300-2022-14436.The report was submitted in error., corrected data: corrected information provided in h10.
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Search Alerts/Recalls
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