INFANT BREATHING CIRCUIT

Report

Report Number: 9611451-2008-00310
Event Type: Malfunction
Date Received: May 22, 2008
Date of Event: April 11, 2008
Report Date: April 22, 2008
Manufacturer: FISHER & PAYKEL HEALTHCARE, LTD.
Product Code: BZE
PMA / PMN Number: K034026
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED TO THE MFR. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE WITH SIMILAR COMPLAINTS. RESULTS: WE WERE UNABLE TO CARRY OUT A LOT CHECK AS NO LOT INFO WAS PROVIDED WITH THIS COMPLAINT. THE DUCKBILL SUCTION PORT CONTAINS A ONE WAY DUCKBILL VALVE AND IS POSITIONED AT THE ELBOW OF THE Y-PIECE. THE FACT THAT A LEAK WAS DETECT IN THE RT236 BREATHING CIRCUIT ONLY UNTIL THE OPERATOR OCCLUDED THE DUCKBILL SUGGESTS THERE WAS A LEAK IN THE DUCKBILL VALVE. CONCLUSION: ALL BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION. THE TEST HAS A SMALL ACCEPTABLE PRESSURE DROP AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT A LEAK IN THE DUCKBILL DEVELOPED AFTER PRODUCTION. WE HAVE AN OPEN CAPA ITEM TO ADDRESS SUCH COMPLAINTS AND TO PUT MEASURES IN PLACE TO REDUCE AND/OR PREVENT RECURRENCE. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0037%.

Description of Event or Problem · 1

A HOSP REPORTED THROUGH OUR DISTRIBUTOR THAT A LEAK WAS DETECTED DURING SETUP FOR A QUANTITY OF 2 INFANT BREATHING CIRCUITS. IT WAS REPORTED THE CIRCUIT PASSED THE LEAK TEST WHEN THE OPERATOR OCCLUDED THE DUCK BILL SUCTION PORT. THE CIRCUITS WERE THEN USED ON THE PT WITH NO APPARENT PROBLEM. NO PT CONSEQUENCE WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFANT BREATHING CIRCUIT		BZE	FISHER & PAYKEL HEALTHCARE, LTD.	RT236

Patients

Seq	Age	Sex	Outcome	Treatment
1				SERVO I VENTILATOR