Catalog Number 300105405 |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2022 |
Event Type
malfunction
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Event Description
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The event involved a plum 360 driver.The customer reported that the pump was not infusing a four-hour chemotherapy treatment of oxaliplatin despite it having correct manual programming.Although the oxaliplatin infusion was checked by two nurses during the afternoon, another nurse checked the pump again and discovered that no infusion had gone through.All of the fluid was left in the container when the issue was noted.There was no alarm of the pump.The time the infusion started was 1130 with a prescribed pump setting of 500ml bag over 4hrs on line a with no filter.The volume of the bag upon the start of the infusion was 500ml bag + the drug.The customer did not report any difficulty in programming or initiating the infusion.There was patient involvement and a delay in therapy.However, there was no medical intervention provided and no report of human harm as a result of the reported event.
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Manufacturer Narrative
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The device has been received.Investigation is pending.
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Manufacturer Narrative
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The device was returned for evaluation.No delivery related alarms found in device history.Device history downloaded and maintained.Detailed review period 28 jan 2022 to 28 feb 2022.The logs for this device were reviewed with focus on log entries for week up to stated event date (2 feb 2022).It can be seen for detailed log analysis that no programmed delivers match the customer reported program.The device passed all pvt testing including delivery accuracy testing.As there are no infusions recorded on the device matching the customer¿s programming specifications, and device passed all testing, the customer¿s complaint could not be confirmed.The customer's complaint was not confirmed as not confirmed through logs and not replicated during testing.
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Search Alerts/Recalls
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