MAUDE Adverse Event Report: CAREFUSION FILTER HEPA 20/CS; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number 001852-A

Device Problem Complete Blockage (1094)

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

Event Date 12/20/2013

Event Type  malfunction  

Event Description

Customer states there were two incidents of patient distress, but they are not sure this was related to the filter.  staff reports it is difficult to see color changes in the filter (eg.During, or after medication treatment are given).  additional information was obtained from the clinical risk coordinator on (b)(6) 2013.  one unit was affected and was in use on the patient.  the ventilator alarmed for increased peak pressure-the peak pressure value is unknown.The circuit and ventilator were immediately changed while the patient was manually ventilated and the issue was resolved without patient impact.After changing the circuit, the clinician noticed that the filter appeared clogged.  also, it was reported that clinician uses brovana and cholistine medications and it is difficult to detect color changes in the filter.Lot number is unknown.Product was discarded and won¿t be available.

Manufacturer Narrative

(b)(4).Sample was not available for evaluation.Upon carefusion's investigation, a follow up medwatch will be submitted.

• Brand Name: FILTER HEPA 20/CS
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali 2160 0; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3575234
• MDR Text Key: 4036074
• Report Number: 8030673-2014-00089
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K850265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Model Number: 001852-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention