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Catalog Number 50000000 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The reported issue was confirmed.It was concluded that the following was the root cause: supplier ¿ root cause inadequate verification and validation activities of the crimping process.Single pull test did not provide stability of process.Evidence was not provided when requested for maintenance of records or crimp tools.No crimp cross-sections provided.A dhr review is not required.Labeling review is not required because labeling could not have prevented this issue.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that the arctic sun device would not fill, water stopped midway up fill tube, there was a failed circulation pump.System hours were 5000, requested a quote for 2000-hour service.Per sample evaluation results on (b)(6) 2024, it was determined that the ac cca card and power module has degraded due to electrical overstress and observed low/marginal flow.
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Search Alerts/Recalls
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