Patient demographics such as age, date of birth, gender, and weight were not provided by the customer.A definitive root cause of the event could not be determined with the available information.Carefusion continues to track and trend any incident related to this issue.(b)(4).All related medwatch reports associated with this incident: 2021710-2015-01924, 2021710-2015-01925, 2021710-2015-01926, 2021710-2015-01934, 2021710-2015-01935, 2021710-2015-01936, 2021710-2015-01937, 2021710-2015-01938, 2021710-2015-01939, 2021710-2015-01940, 2021710-2015-01942, 2021710-2015-01943, 2021710-2015-01944, 2021710-2015-01945, 2021710-2015-01946, 2021710-2015-01947, 2021710-2015-01948, 2021710-2015-01949, 2021710-2015-01950, 2021710-2015-01951, 2021710-2015-01962, 2021710-2015-01964,, 2021710-2015-01965, 2021710-2015-01966, 2021710-2015-01968, 2021710-2015-01970, 2021710-2015-01972, 2021710-2015-01973.(b)(4).
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The customer reported questionable elevated diffuse lung carbon monoxide (dlco) values for twenty-eight (28) patients for pulmonary function analysis while utilizing the vmax encore 22 system.This report references patient twenty-three of twenty-eight.The customer stated all 28 patients' results were released to the physician; however, there was no patient impact.The customer informed the physician of the incorrect results prior to any medical decision.The customer stated the 28 patients were retested and corrected results were issued to the physician.The customer also noted there was no system alarm at the time of the reported issue.The data received from the customer did not show issues with gas tracings, and no errors were noted.Notable were larger than normal inspiratory vital capacity (ivc), and alveolar volume (va) values, which were likely responsible for dlco values in excess of 160% reference for multiple patients that were being tested.The customer replaced all lines and tubing, as well as the mass flow sensor (mfs) and balloon valve assembly (bva) prior to the event.Review of the most recent mfs calibration, (which passed without error) shows correction factors as: inspire = 1.68 lps expire = 1.92 lps.The customer was then instructed to examine the calibration hose and noticed a large tear in the hose.The customer replaced the calibration hose and noted the correction factors were approximately 1.007 lps for inspire and expire.The reported issue was resolved, and the unit was returned to normal operation.No further issues were noted.
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