MAUDE Adverse Event Report: CAREFUSION, INC KIT PREFILL NEB W NEB CAP STERILE WATER; HUMIDIFIER NEBULIZER KIT

Catalog Number CK0010

Device Problem No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission.At this time, the device is in the process of being evaluated.Once the evaluation is complete a follow up report will be filed.(b)(4).

Event Description

Customer reported ¿the cap on the ck0010 is difficult to attach to flowmeter.The patient had a rapid response call due to low oxygen saturation.The device led to a low saturation due to the device appearing to be attached to the flowmeter yet there was no flow reaching the patient.The device either cross threaded or did not thread fully, also the top piece separated.Patient demographics are irrelevant in this situation and will not be shared".

Manufacturer Narrative

Investigation results: one sample was received and evaluated.The adapter was tested with a gauge to simulate threading the device to a bottle.The sample was able to be threaded without an issue.The sample was functionally tested and it was found that the adapter does not nebulize related to a disassembly of the tubing with p/n (b)(4) to the cap.The complaint reported is confirmed.The device history record for the lot number reported was reviewed and no issues related to the failure mode were found.The root cause of the reported issue is related to manufacturing personnel accumulating more units in the bin that the specified on the instruction procedure.Therefore, the tubing may have disassembled due to the over accumulation of product in the bins.To correct and prevent this issue, personnel were retrained on the procedure.

• Brand Name: KIT PREFILL NEB W NEB CAP STERILE WATER
• Type of Device: HUMIDIFIER NEBULIZER KIT
• 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: 6380984
• MDR Text Key: 69163593
• Report Number: 8030673-2017-00295
• Device Sequence Number: 1
• Product Code: OGG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CK0010
• Device Lot Number: 0001040503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention