FDA Adverse Event Malfunction Summary report: N

TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

MDR report key: 1843255 · Received September 24, 2010

Report

Report Number: 2015691-2010-14110
Event Type: Malfunction
Date Received: September 24, 2010
Date of Event: August 15, 2010
Report Date: August 25, 2010
Manufacturer: EDWARDS LIFESCIENCES DR
Product Code: DXO
PMA / PMN Number: K925638
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER REPORTED DEFECT WAS CONFIRMED AND BLOOD WAS VISIBLE INSIDE THE VAMP RESERVOIR. THE PRESSURE TUBING WAS FOUND COMPLETELY BROKEN OFF FROM SOLVENT BOND JOINT WITH FEMALE CONNECTOR THAT WAS ATTACHED TO DPT ZERO-STOPCOCK. THE FEMALE CONNECTOR AND ATTACHED DPT WERE NOT RETURNED WITH THE KIT. TUBING WAS BENT NEAR THE POINT OF DAMAGE. CROSS SURFACE OF BROKEN TUBING APPEARED UNEVEN AND ROUGH. THE REPORTED DEFECT WAS CONFIRMED TO BE A MANUFACTURING DEFECT. THE DIRECTIONS FOR USE AND STANDARD NURSING PROCEDURES CALL FOR INSPECTING THE DEVICE AND PRIMING THE LINES WITH SALINE PRIOR TO USE ON THE PATIENT. THE LEAK WILL BE DETECTED DURING THE PRIMING PROCESS, MAKING IT UNLIKELY THAT THIS NON-CONFORMANCE WILL EVER RESULT IN AN INJURY.

Description of Event or Problem · 1

REPORTEDLY, WHEN MOVING THE IV POLE TO WHICH THE TUBING KIT WAS ATTACHED, THE TUBING WAS CUT. NO PATIENT INJURY WAS REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE RUBBER COVER AND OVER THE AUDIO BOLUS BUTTON AND "ADDITIONAL PIECES" CAME OFF THE PUMP. THE PT INDICATED THAT THE AUDIO BOLUS BUTTON WAS STICKING AND THE PUMP WOULD NOT RESPOND TO BUTTON PRESSES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TRUWAVE DISPOSABLE PRESSURE TRANSDUCER	DISPOSABLE PRESSURE TRANSDUCER	DXO	EDWARDS LIFESCIENCES DR	T001672A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1