Model Number 21-7364-24 |
Device Problem
Inaccurate Delivery (2339)
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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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Other text: 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 customer had several complaints from patients about their infusion bags running out before the scheduled times and that the problem may be with the tubing.The device delivered 53.8ml after programming for 50ml.This did not meet a +/-6% threshold.All were tested with the same pump.
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Manufacturer Narrative
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Other text: additional information is provided for h.2 and h.6.No product was returned.The reported complaint could not be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.If the product is returned this complaint will be reopened for further investigation.G1, email address: (b)(4).
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Search Alerts/Recalls
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