FDA Adverse Event Malfunction Summary report: N

NDEHP PRIMARY PLUM CLAVE Y

MDR report key: 1676475 · Received April 29, 2010

Report

Report Number: 9615050-2010-00076
Event Type: Malfunction
Date Received: April 29, 2010
Date of Event: January 1, 2010
Report Date: April 6, 2010
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: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K865060. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS BEING USED FOR A 3 HOUR DELIVERY OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. IT WAS REPORTED THAT AFTER APPROXIMATELY 30 MINUTES IN USE, THE PATIENT NOTIFIED THE NURSE TO REPORT THAT THE PUMP WAS ALARMING. AT THIS TIME, IT WAS NOTED THE SOLUTION CONTAINER WAS EMPTY AND THE FLOOR WAS WET. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF THE SOLUTION HAD LEAKED ONTO THE FLOOR. THE LOCATION OF THE LEAK WAS NOT SPECIFIED. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SET AND THE SOLUTION CONTAINER WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NDEHP PRIMARY PLUM CLAVE Y	UNK	FPA	HOSPIRA COSTA RICA LTD.	NA	810195H

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK