ADULT UNHEATED BREATHING CIRCUIT

Report

Report Number: 9611451-2013-00159
Event Type: Malfunction
Date Received: March 5, 2013
Date of Event: January 31, 2013
Report Date: February 7, 2013
Manufacturer: FISHER & PAYKEL HEALTHCARE LIMITED
Product Code: BTT
PMA / PMN Number: K033710
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). METHOD: THE DRYLINE TUBES OF THE COMPLAINT RT134 ADULT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT BOTH DRYLINE TUBES SUSTAINED A HOLE, ABOUT 17.5CM AWAY FROM THE CONNECTOR. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 120305. CONCLUSION: IT WAS IDENTIFIED THAT DAMAGE TO THE RT134 DRYLINES WAS CAUSED BY A FAULTY CORRUGATOR BLOCK THAT WAS USED DURING THE DRYLINE MANUFACTURING PROCESS. THE FAULTY BLOCK WAS LAST YEAR. THE COMPLAINT DRYLINE TUBES WERE MANUFACTURED PRIOR TO THE REPLACEMENT OF THE FAULTY CORRUGATOR BLOCK. DURING THE PRODUCTION OF THE DRYLINE TUBES, A PRESSURE TEST IS PERFORMED EVERY (B)(4) AND THOSE THAT FAIL ARE SET ASIDE FOR FURTHER INSPECTION. THE USER INSTRUCTIONS FOR THE RT134 ADULT UNHEATED BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS." (B)(4).

Description of Event or Problem · 1

A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT TWO RT134 ADULT UNHEATED BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. IT WAS FURTHER REPORTED THAT A PINHOLE WAS FOUND ON EACH OF THE DRYLINE TUBE. THIS WAS OBSERVED BEFORE PATIENT USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
93616	ADULT UNHEATED BREATHING CIRCUIT	BTT	BTT	FISHER & PAYKEL HEALTHCARE LIMITED	RT134	120305

Patients

Seq	Age	Sex	Outcome	Treatment
1