CAREFUSION, INC STATIC AND DYNAMIC COMPLIANCE; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
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Model Number 22 E |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/07/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Results of investigation: the device was returned and evaluated by a carefusion factory service technician.The reported issue, of the sample pump being noisy and the gas was free flowing, was duplicated.The sample pump and the demand valve were replaced, which resolved the reported issue.The device was tested and passed to service specifications, then returned to the customer.The carefusion failure analysis laboratory performed a failure investigation on the suspect components but could not create the failure in the laboratory setting.A root cause of the reported failure could not be identified.The component was returned to the manufacturer for further evaluation.Upon receipt of the completed failure investigation, a supplemental report will be submitted.
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Event Description
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The customer reported getting low volumes, having a noisy sample pump and gas free flow.She also stated that they had a (b)(6) patient diagnosed with testicular cancer with bilateral lung masses that had one pulmonary function test (pft) a month, for four months, starting in (b)(6) 2015 and the last one was in (b)(6) 2015.In (b)(6) the pft was showing normal lung values.The following months showed decreasing diffusion and restricted volumes with the last diffusion showing 53% in (b)(6).The patient was receiving aggressive chemotherapy called bleomycin which has a side effect of decreased lung function.It was advised that the patient discontinue chemotherapy based on his pft results.However, the clinician was concerned after having multiple module replacements in the previous months and she doubted the reliability of the results.It is unknown what happened to the patient because the patient did not return after (b)(6) 2015.
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