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Model Number 21-7302-24 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2021 |
Event Type
malfunction
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Event Description
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Information was received indicating that the cadd cassette reservoirs - flow stop leaked during use with a patient.There were no adverse events reported.
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Manufacturer Narrative
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Other, other text: additional information: d10, h6, h10: three pictures of smiths medical cadd cassette reservoir were received.In pictures, no damage could be detected in the sample.Device evaluation: one smiths medical cadd cassette reservoir was returned for analysis in a used condition.Leak testing on the sample received was performed using a syringe to look for unusual functions.The sample was filled without issues; no leaks were found during the test.The complaint is not confirmed.Based on the evidence, the complaint was not confirmed, and no fault was found.
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Manufacturer Narrative
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Other text: additional information after investigation of device a functional test was performed on device, the sample presented a leak in the joint of the tube of the bag.The reported problem was confirmed.The root cause of the reported issue was found to be manufacturing equipment failure of bag sealer machine, and as a procedural failure where process was not followed as is required, forcing the equipment to release parts with potential leak condition.Corrective and preventive action (capa) was initiated and the results of capa were implemented by the concerned department to resolve the reported problem.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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