FDA Adverse Event Malfunction Summary report: N

CADD-PRIZM VIP AMBULATORY INFUSION PUMP

MDR report key: 2894960 · Received January 11, 2008

Report

Report Number: 2183502-2007-00389
Event Type: Malfunction
Date Received: January 11, 2008
Date of Event: December 9, 2007
Report Date: December 14, 2007
Manufacturer: SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
Product Code: MEA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE REPORTER HAD INITIALLY CONTACTED THE DEVICE MFR REQUESTING THE DEVICE HISTORY FOR THE DEVICE INVOLVED IN AN INCIDENT BE DOWNLOADED. THEN INITIAL REPORTER STATED THAT THERE WAS NO DEVICE MALFUNCTION. THE DEVICE HAD BEEN REPROGRAMMED BY THE NURSE IN THE FIELD AND THEY NEEDED THE RECORD. THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. DELIVERY AND ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL DELIVERY AND ACCURACY TESTS. THE PUMP HISTORY WAS DOWNLOADED AND SENT TO THE INITIAL REPORTER AS REQUESTED. NO OPERATIONAL OR FUNCTIONAL FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPEC. ADD'L INFO: DEVICE AVAILABLE FOR EVAL: (B)(4) 2007.

Description of Event or Problem · 1

CADDPRIZM PUMP PROGRAM WAS CHANGED IN FIELD BY HOSPICE OF THE COMFORTER NURSE. PUMP PROGRAMMED BY PHARMACY TO DELIVER DILAUDID IN MG/HR. NURSING PROGRAMMED PUMP TO DELIVER ML/HR. PT SHOULD HAVE RECEIVED 9 MG OF DILAUDID OVER AN HOUR. THE PT RECEIVED 9 ML OVER AN HOUR. THE CONCENTRATION OF THE MEDICATION WAS 5MG/ML GIVING THE PT 45 MG OF DILAUDID OVER AN HOUR, INSTEAD OF 9 MG OVER AN HOUR. BOLUS (DEMAND DOSE) WAS SET TO 4 ML FROM 4 MG.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CADD-PRIZM VIP AMBULATORY INFUSION PUMP	AMBULATORY INFUSION PUMP, CADD PUMP	MEA	SMITHS MEDICAL MD (FORMERLY DELTEC, INC)	21-8921	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Hospitalization\| L