MAUDE Adverse Event Report: CAREFUSION STATIC AND DYNAMIC COMPLIANCE; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number 22 E

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

(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).

Event Description

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 ten 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.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5167413
• MDR Text Key: 29333509
• Report Number: 2021710-2015-01940
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22 E
• Device Catalogue Number: 777543-102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• Date Device Manufactured: 04/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1