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Model Number 21-7336-24 |
Device Problems
Material Fragmentation (1261); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/13/2020 |
Event Type
malfunction
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Event Description
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Information was received indicating that during infusion of an oncology treatment via a smiths medical cadd administration set, a break in the line was observed.The break was noted to be located between the cassette and iv bag.It was reported that during a nursing check, the backpack which contained the pump, iv bag, and administration set was found wet.The infusion was then stopped, and a new administration set and iv bag was used.There were no reported adverse patient effects.
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Manufacturer Narrative
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Other, other text: h3: one cadd administration set from part number 21-7336-24 with an unknown lot number was received for evaluation.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.A kink in the extension tube was found.Relevant documents were reviewed and deemed adequate and correct with respect to testing and inspection activities.The tube sample was used for replicating the failure mode reported.The clip was activated in the tube damaged in order to verify; no damages could be replicated.The housing ffp was pushed against the tube to try to replicate the failure mode, no damages were created.A fixture for assembly process was used for replicated the damaged reported, a similar damaged in tube was created.The reported issue was able to be confirmed.The most probable root cause is that during assembly process the fixture slipped and created a damage in the tube.
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Search Alerts/Recalls
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