FDA Adverse Event Malfunction Summary report: N

MICR GEMSTR CLV Y-SITE PE LNED ORNG 96IN

MDR report key: 3901995 · Received May 7, 2014

Report

Report Number: 9615050-2014-03279
Event Type: Malfunction
Date Received: May 7, 2014
Date of Event: March 1, 2014
Report Date: April 9, 2014
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FRN
PMA / PMN Number: K060806
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED A LEAK. THE TUBING SET WAS BEING USED TO DELIVER PROLEUKIN 3 MILLION IU/DAY, WITH A VOLUME TO BE INFUSED (VTBI) OF 144ML, AT A RATE OF 1.5ML/HR, FOR THE DURATION OF 4 DAYS, VIA A GEMSTAR PUMP. THE CUSTOMER CONTACT REPORTED THAT THE HEMOCARE PT'S FAMILY MEMBER STARTED THE DELIVERY. NO SPECIFIC DETAILS WERE PROVIDED. IT WAS REPORTED THAT APPROX 5-6 HOURS AFTER THE DELIVERY WAS STARTED, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT THE DISTAL CONNECTION OF THE CASSETTE AND THE TUBING OF THE TUBING SET. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SET WAS REPLACED. IT WAS REPORTED THAT WITHIN 4 HOURS, A NEW SOLUTION WAS COMPOUNDED AND SENT TO THE PT'S HOME. AFTER AN UNSPECIFIED LENGTH OF TIME, THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE FAMILY MEMBER OR PT AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADD'L INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
276870	MICR GEMSTR CLV Y-SITE PE LNED ORNG 96IN	80FRN	FRN	HOSPIRA COSTA RICA LTD.	NA	930335H

Patients

Seq	Age	Sex	Outcome	Treatment
1	9 YR			UNSPECIFIED GEMSTAR PUMP, LIST #UNK, SN UNK