Model Number 21-7022-24 |
Device Problems
Device Alarm System (1012); Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2023 |
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 additional reportable information becomes available.
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Event Description
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It was reported that a syringe from the bag into the tubing had to be used, as the solution was not running freely.This was experienced with five patients during a two day period.In each of the cases, the patient reported that the pump started beeping while the medication was being infused at home.No patient injury reported.
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Manufacturer Narrative
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Evaluation: the returned samples were received in unused conditions.No damages or other defects were detected on the samples.No discrepancies were detected on the samples, the test successfully passed with a result within specification (average delivery error acceptable is -7% to 7 for disposable accuracy test reports)) thus, the failure mode reported is not confirmed.Root cause cannot be determined since complaint was not confirmed.Action taken is not required since complaint was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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Search Alerts/Recalls
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