FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2942055 · Received February 4, 2013

Report

Report Number: 1416980-2013-02826
Event Type: Malfunction
Date Received: February 4, 2013
Date of Event: January 15, 2013
Report Date: January 15, 2013
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FPA
PMA / PMN Number: K961225
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. IF RELEVANT ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

A CUSTOMER CONTACTED A BAXTER CLINICAL SERVICES CONSULTANT TO REPORT AN ISSUE WITH ONE CLEARLINK SECONDARY MEDICATION SET. ACCORDING TO THE REPORT, THE CUSTOMER STATED THAT THEY WERE EXPERIENCING MULTIPLE UPSTREAM OCCLUSION ALARMS, WITH NO READILY APPARENT CAUSE, WHILE THE SET WAS BEING USED WITH A SIGMA SPECTRUM PUMP. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
46017	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - SINGAPORE		SR12J09015

Patients

Seq	Age	Sex	Outcome	Treatment
1				SIGMA SPECTRUM PUMP