FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2120778 · Received June 10, 2011

Report

Report Number: 6000001-2011-07538
Event Type: Malfunction
Date Received: June 10, 2011
Date of Event: May 1, 2011
Report Date: May 17, 2011
Manufacturer: BAXTER HEALTHCARE
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE PRODUCT CODE OF THIS DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

Additional Manufacturer Narrative · 1

(B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

A CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE (CPS) OF AN UNKNOWN QUANTITY OF UNSPECIFIED BAXTER TUBING IN WHICH DUE TO A PRODUCT CHANGE (DIFFERENT FILTER) THERE IS DIFFICULTY REMOVING AIR FROM THE TUBING DURING PRIMING ON UNKNOWN DATE(S). THE CUSTOMER HAS TO USE AT LEAST 50ML OF FLUID DURING PRIMING AND THAT SHE IS STILL UNABLE TO PRIME THE SET SINCE AIR IS STILL IS PRESENT. TAPPING THE FILTER AND TURNING IT UPSIDE DOWN DID NOT ASSIST IN REMOVING THE AIR BUBBLES. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1				UNKNOWN FILTER