Model Number 50000000 |
Device Problem
Insufficient Cooling (1130)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.
Once the investigation is complete a supplemental report will be filed.
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.
The device was not returned.
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Event Description
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It was reported that the data file showed alert 113 due to the arctic sun device not cooling and a review of the data showed a failed mixing pump.
Per additional information received on (b)(6) 2022, it was stated that the arctic sun device was not used on patient during the reported issue.
|
|
Manufacturer Narrative
|
The investigation is still in progress.
Once the investigation is complete a supplemental report will be filed.
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.
The device was not returned.
|
|
Event Description
|
It was reported that the data file showed alert 113 due to the arctic sun device not cooling and a review of the data showed a failed mixing pump.
Per additional information received on (b)(6) 2022, it was stated that the arctic sun device was not used on patient during the reported issue.
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Search Alerts/Recalls
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