FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 3250590 · Received July 26, 2013

Report

Report Number: 1416980-2013-19914
Event Type: Malfunction
Date Received: July 26, 2013
Report Date: July 2, 2013
Manufacturer: BAXTER HEALTHCARE - MALTA
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SN
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL INSPECTION OF THE SAMPLE CONFIRMED THE REPORTED CONDITION REVEALING THE SAMPLE HAD A DOUBLE LOOP OF TUBING IN THE ROLLER CLAMP. THE CAUSE WAS DETERMINED TO BE THE MACHINE WHICH DID NOT ASSEMBLE THE INVOLVED SET CORRECTLY. IMPROVEMENTS HAVE BEEN MADE TO THE ASSEMBLY MACHINES. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

Description of Event or Problem · 1

IT WAS REPORTED THAT A FLOGARD ADMINISTRATION SET HAD TWO PIECES OF TUBING BENEATH ONE OF THE ROLLER CLAMPS. THIS EVENT WAS DISCOVERED PRIOR TO PRODUCT USE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
350571	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - MALTA		12C31V818

Patients

Seq	Age	Sex	Outcome	Treatment
1