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  Other  

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) (our eu representative) and then forwarded to carefusion (b)(4)."pt was treated in cpap for a week and mask was used.Cpap prong couldn't be used since it was not possible to apply these at all.Staff alternated between size small and medium and as well as between bonnets and headgear.Nevertheless, this caused a pressure sore between the nostrils.This is twin (b)(6), first twin was treated exactly the same way.(b)(6).Was also possible to wean from ncpap, sores treated exactly the same way and related nicely too.Same issues with lp masks and prongs as the other twin.".

Manufacturer Narrative

(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): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: antonio cervera ; 7607787307
• MDR Report Key: 3608222
• MDR Text Key: 4171777
• Report Number: 2021710-2014-00003
• 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: 01/23/2014
• 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: 777002M & 777002S
• Device Lot Number: 0000406373
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/10/2013
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FISHER PAYKEL HUMIDIFIER MR 850: SN: (B)(4); SN: (B)(4); CAREFUSION INFANT FLOW SIPAP DRIVER:
• Patient Age: 10 DA
• Patient Weight: 1