MAUDE Adverse Event Report: CAREFUSION, INC ASSY, PAT CIR ADULT W / PEEP, SPUX10; CIRCULATOR, BREATHING-CIRCUIT

Catalog Number 29695-001

Device Problem Leak/Splash (1354)

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

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Used circuit coming in for investigation.Failed at the peep/exhalation valve.Low peep pressures, loss of peep and low exhale volume return.Changed circuit "no harm or injury to the resident.Clinical changes that occurred: increase in etc02.Circuit passed the pre-use check.Intervention: circuit removed, resident bagged, new circuit obtained, tested and passed then connected to resident.Sample was sent to carefusion".

Manufacturer Narrative

One open and contaminated circuit was received at the palm springs failure analysis lab.During bench test the sample was found working only intermittently with low peep pressures, loss of peep and low exhale volume.Further testing was not possible due to the contamination.The sample was sent to the decontamination facility in vernon hills and then sent to the quality engineers at the mexicali factory for final evaluation.Unfortunately the sample could not be completely cleaned residue remained in the tube.The device history record was reviewed and no issues were found.Two years of complaint trends were also reviewed and no trend was detected.Due to the residual contaminate no further functional testing could be performed.A visual inspection was performed but this was also very limited and unfortunately a root cause could not be determined.After a thorough review of the manufacturing procedure an improvement was identified.The procedure will be updated to clarify the correct method to perform the peep valve test.Personnel have been notified of the potential failure and further training has been done.(b)(4).

• Brand Name: ASSY, PAT CIR ADULT W / PEEP, SPUX10
• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway dr; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6503765
• MDR Text Key: 73179556
• Report Number: 8030673-2017-00324
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 29695-001
• Device Lot Number: 0001045341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention