FDA Adverse Event Malfunction Summary report: N

INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

MDR report key: 2515742 · Received April 3, 2012

Report

Report Number: 9611451-2012-00200
Event Type: Malfunction
Date Received: April 3, 2012
Date of Event: February 27, 2012
Report Date: March 12, 2012
Manufacturer: FISHER & PAYKEL HEALTHCARE LTD
Product Code: BZE
PMA / PMN Number: K034026
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). METHOD: THE RETURNED COMPLAINT CIRCUIT KIT WAS RECEIVED UNSEALED AND PACKED IN A PLASTIC BAG. THE CONTENTS WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE LUER PORT CAP WAS MISSING FROM THE DRY LINE CONNECTOR, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110729. CONCLUSION: EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT OPERATOR ERROR HAS RESULTED IN THE FAILURE TO FIT THE LUER PORT CAP. THERE ARE STANDARD OPERATING PROCEDURES IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK THE BREATHING CIRCUITS. THIS CONSISTS OF A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED WHICH MUST BE DISPLAYED AT THE PACKING STATION. OUR MONITORING AND TRENDING OF MISSING OR WRONG CONNECTORS IN INFANT BREATHING CIRCUIT COMPONENTS HAS A RATE OF OCCURRENCE OF (B)(4) DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF MARCH 2012.

Description of Event or Problem · 1

A HOSPITAL IN (B)(6) REPORTED THAT WHEN THEY OPENED AN RT235 INFANT BREATHING CIRCUIT KIT, THEY NOTICED THAT THE GAS PORT CAP WAS MISSING FROM THE DRY LINE. THIS WAS FOUND BEFORE USE ON A PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT	BZE	BZE	FISHER & PAYKEL HEALTHCARE LTD	RT235	110729

Patients

Seq	Age	Sex	Outcome	Treatment
1