MAUDE Adverse Event Report: CAREFUSION 203, INC LTV PATIENT CIRCUIT; CIRCUIT, BREATHING

Model Number 11558X10

Device Problems Device Alarm System (1012); Sticking (1597); Difficult to Open or Close (2921); Infusion or Flow Problem (2964)

Patient Problems Dyspnea (1816); Respiratory Distress (2045)

Event Type  Injury  

Event Description

It was reported that the peep valve on patient circuit was stuck open and was not giving any air to patient.The patient was in distress and was manually ventilated.The low pressure alarm settings were too low and the alarm volume was turned down.No alarm was detected because of the ventilator alarm settings.No patient harm reported.

• Brand Name: LTV PATIENT CIRCUIT
• Type of Device: CIRCUIT, BREATHING
• Manufacturer (Section D): CAREFUSION 203, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer (Section G): CAREFUSION 203, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer Contact: jennifer huybrecht ; 7633988395
• MDR Report Key: 3803267
• MDR Text Key: 4386694
• Report Number: 2031702-2014-00122
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 11558X10
• Device Catalogue Number: 11558X10
• Other Device ID Number: RMA 235973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2000
• 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
• Patient Outcome(s): Life Threatening; Required Intervention