FDA Adverse Event Malfunction Summary report: N

NDEHP PRIMARY PLUM PREPIERCED Y

MDR report key: 2270578 · Received September 14, 2011

Report

Report Number: 9615050-2011-00707
Event Type: Malfunction
Date Received: September 14, 2011
Date of Event: August 1, 2011
Report Date: August 24, 2011
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FPA
PMA / PMN Number: UNK
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80 FRN AND HAS A 510 K OF K865060. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. 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 OF A CHEMOTHERAPEUTIC AGENT. THE PRIMARY PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF FARMORUBICIN, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT A LEAK OF SOLUTION WAS NOTED AT AN UNSPECIFIED LOCATION. THE PLUMSET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED INCLUDING DETAILS ON HOW THE SOLUTION THAT LEAKED WAS CLEANED UP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NDEHP PRIMARY PLUM PREPIERCED Y	UNK	FPA	HOSPIRA COSTA RICA LTD.	NA	021335H

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			PLUM PUMP: LIST# UNK, SN UNK