MAUDE Adverse Event Report: CAREFUSION, INC PACKAGE ASSEMBLY,INFANT FLOW,LP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number 7772020LP

Device Problem Partial Blockage (1065)

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

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At this time we are awaiting for the sample to be returned by the customer/distributor.If any additional information becomes available a supplemental submission will be filed.(b)(4).

Event Description

Pressure line is blocked by unidentified, unspecified component.Fortunately the fault was discovered by staff during setting up of the equipment before connecting to the patient.The occlusion appears to be in the pressure monitoring tube adjacent to the round molding near the patient end.

Manufacturer Narrative

Sample was provided and was visually and functionally inspected.The sample failed the generator pressure test.During visual inspection the sample was found to be blocked with excess solvent between the tubing and a connector.The reported issue was confirmed.A two year retrospective review was conducted on complaints and no trend was identified related to this issue.During assembly the tubing and the connector are assembled with solvent.However, the operator needs to remove excess solvent prior to assembling the two components.It was noticed during the manufacturing process review that the method to remove the excess solvent is not well defined on how to avoid the tube from being occluded with excess solvent.To correct this issue, the procedure was modified to clarify the method to remove the excess solvent.Assembly personnel were notified of this issue and retrained on the procedure.

• Brand Name: PACKAGE ASSEMBLY,INFANT FLOW,LP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 5887070
• MDR Text Key: 53453528
• Report Number: 8030673-2016-00207
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7772020LP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1