FDA Adverse Event Malfunction Summary report: N

GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM

MDR report key: 3070167 · Received April 15, 2013

Report

Report Number: 9615050-2013-00736
Event Type: Malfunction
Date Received: April 15, 2013
Date of Event: March 21, 2013
Report Date: March 22, 2013
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FRN
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 DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K060806. 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 SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A GEMSTAR PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE PUMP ALARMED FOR AN UNSPECIFIED ALARM. AT THIS TIME, IT WAS NOTED THAT THE TUBING HAD SEPARATED FROM AN UNSPECIFIED LOCATION OF THE CASSETTE OF THE TUBING SET. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. THROUGH REQUESTED, NO ADD'L INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
160749	GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM	UNK	FRN	HOSPIRA COSTA RICA LTD.	NA	UNK5H

Patients

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