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Model Number 21-7106-24 |
Device Problem
False Alarm (1013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2022 |
Event Type
malfunction
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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 required.
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Event Description
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It was reported that during the use of an extension tube, a high pressure alarm went off.Immediately after the patient started performing a priming, the alarm was issued.The patient changed the pump to another one, but the alarm persisted.The extension tube was then changed to another one and after that the system (the pump and the tube) got back working normally.So the patient suspected there was an anomaly in the extension tube.There was no patient injury.
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Manufacturer Narrative
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Other, other text: h6: h10: 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 and functional testing was performed.Visual inspection found an occlusion between the tube and filter.Functional testing found the alarm was activated, so the reported failure mode is confirmed.The root cause of the reported issue was found to be manufacturing.Excess of solvent in one of the bonding unions (luer - tubing union / tubing ? filter union) generate occluded tube.Awareness notification was generated to explain the importance to follow up correctly the bonding process documented in procedure ? completed by the quality engineer on (b)(6) 2023.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Search Alerts/Recalls
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