Model Number 21-7359-24 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2022 |
Event Type
malfunction
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Event Description
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It was reported that the device had a loose component which should be fixed to the extension.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
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Manufacturer Narrative
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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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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual inspection found damage under the pump tube was detected.No other analysis was performed.The root cause of the reported issue was found to be manufacturing - uv automatic dispense system incorrectly setup.The following actions were taken: pm-297 was updated on 30-sep-2016 to added the specification range drop size for bond pump tube to housing operation and added adhesive application instructions to clarify the procedure.Visual aid was created and referenced on pm-297 on 06-jun-2017 to provided visual acceptance criteria for bonding of the pump tube to housing.Pm-297 was updated on 24-nov-2017 to added certified personnel as requirement for inspection of the bond pump tube to housing operation this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Event Description
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It was reported that the fixed part of the extension is loose, impairing the administration of the medication, which ended up not being infused.Another manipulation was performed, with no adverse reaction to the patient.
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Search Alerts/Recalls
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