FDA Adverse Event Malfunction Summary report: N

UNK

MDR report key: 2039386 · Received February 23, 2011

Report

Report Number: 9615050-2011-00103
Event Type: Malfunction
Date Received: February 23, 2011
Date of Event: January 1, 2011
Report Date: January 27, 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: CA
Reporter Occupation: OTHER

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 CATALOG NUMBER FOR THE GEMSTAR TUBING SET WAS NOT PROVIDED. THE GEMSTAR TUBING SET HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K060806. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING DISTAL TO THE FILTER. THE GEMSTAR TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION VIA A GEMSTAR PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED "THAT 5 TO 10CM OF AIR" WAS NOTED IN THE TUBING DISTAL TO THE FILTER. IT WAS REPORTED THAT THE HOMECARE PATIENT STOPPED THE DELIVERY. NO AIR WAS DELIVERED TO THE PATIENT. THE TUBING SET WAS 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 REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNK	UNK	FPA	HOSPIRA COSTA RICA LTD.	NA	UNK5H

Patients

Seq	Age	Sex	Outcome	Treatment
1				GEMSTAR 7 THERAPY PUMP: LIST #13087, SN (B)(4)