FDA Adverse Event Other Summary report: N

CAREFUSION

MDR report key: 3608222 · Received January 23, 2014

Report

Report Number: 2021710-2014-00003
Event Type: Other
Date Received: January 23, 2014
Date of Event: December 10, 2013
Report Date: December 10, 2013
Manufacturer: CAREFUSION
Product Code: CAI
PMA / PMN Number: K031745
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(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.

Description of Event or Problem · 1

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."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
54681	CAREFUSION	CIRCUIT, BREATHING/CAI	CAI	CAREFUSION	NASAL MASK	0000406373

Patients

Seq	Age	Sex	Outcome	Treatment
1	10 DA			FISHER PAYKEL HUMIDIFIER MR 850: SN: (B)(4)\| SN: (B)(4)\| CAREFUSION INFANT FLOW SIPAP DRIVER: