FDA Adverse Event Malfunction Summary report: N

GEMSTAR 7 THERAPY

MDR report key: 1930265 · Received November 18, 2010

Report

Report Number: 2921482-2010-00916
Event Type: Malfunction
Date Received: November 18, 2010
Date of Event: October 22, 2010
Report Date: October 22, 2010
Manufacturer: HOSPIRA, INC.
Product Code: FRN
PMA / PMN Number: K060806
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: NURSE

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. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED THAT WHILE OPERATING ON AC POWER, THE PUMP POWERED OFF BY ITSELF WITHOUT SOUNDING AN AUDIBLE ALARM TONE. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED FOR CONTINUOUS PLUS BOLUS DELIVERY OF AN UNSPECIFIED CONCENTRATION OF MORPHINE, WITH A CONTINUOUS RATE OF 4MG/HR, A 2MG BOLUS DOSE, WITH A 12 MG/HR DOSE LIMIT, A 100ML CONTAINER SIZE AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2010 AT 0530, THE PT REPORTED WAKING UP WITH AN INCREASED PAIN. AT THAT TIME, THE PT PRESSED THE BOLUS BUTTON; HOWEVER, NO DOSE WAS DELIVERED AND THE DEVICE WAS REPORTED TO BE POWERED OFF. THE PT REPORTED THERE WAS NO AUDIBLE ALARM TONE TO INDICATE THE DEVICE HAD POWERED OFF. THE CUSTOMER CONTACT REPORTED THE DEVICE WOULD NOT POWER ON USING AC OR BATTERY POWER. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS OR DELAYS IN THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GEMSTAR 7 THERAPY	80FRN	FRN	HOSPIRA, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1