MAUDE Adverse Event Report: CAREFUSION CAREFUSION; CIRCUIT, BREATHING/CAI

Model Number NASAL MASK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 12/10/2013

Event Type  No Answer Provided  

Event Description

The following description of the event was copied from a carefusion customer feedback form submitted to carefusion (b)(4) forwarded to carefusion ((b)(4) representative) and then forwarded to carefusion (b)(4)."patient was treated in a ncpap for a week and mask was used.Cpap prongs couldn't be used since it was not possible to apply these at all.Staff alternated between size small and medium and well as between bonnets and headgear.Nevertheless, this caused a pressure sore between the nostrils." the following additional info regarding the event was copied from an e-mail from a carefusion representative in (b)(4)."customer not reported that they used both lp mask size small and medium.No mask seemed to fit perfect, that's why they alternated between the two sizes.First decision was to try to wean the pt of ncpap, which was successfully done.The sores were cleaned with disinfectant (b)(4) for a few days.Sores healed nicely ater that.".

Manufacturer Narrative

The foreign user facility did not submit a user facility report to the mfr.Event codes were derived based on info provided by the user facility.(b)(4).Nasal irritation, septal distortion, skin irritation and pressure necrosis are known complications of ncpap therapy and this is mentioned in the carefusion infant flow sipap operator's manual and the infant flow lp ncpap system instructions for use.As the carefusion infant flow lp ncpap system is relatively new to the market, the user facility possible lack of experience with this system may have been a contributing factor in the reported event.

• Brand Name: CAREFUSION
• Type of Device: CIRCUIT, BREATHING/CAI
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CARFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: antonio cervera ; 7607787307
• MDR Report Key: 3608292
• MDR Text Key: 4153521
• Report Number: 2021710-2014-00002
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NASAL MASK
• Device Catalogue Number: 777022M & 777002S
• Device Lot Number: 0000406373
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2013
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PAYKEL HUMIDIFIER MR 850 SN (B)(4); CAREFUSION INFANT FLOW SIPAP DRIVER SN (B)(4)
• Patient Age: 10 DA
• Patient Weight: 1