FDA Adverse Event Other Summary report: N

CADD PCA AMBULATORY INFUSION PUMP

MDR report key: 149997 · Received February 13, 1998

Report

Report Number: 149997
Event Type: Other
Date Received: February 13, 1998
Date of Event: January 14, 1998
Report Date: January 16, 1998
Manufacturer: SIMS DELTEC, INC.
Product Code: FRN
Adverse Event: Yes
Report Source: User Facility report
Reporter Location: WA, US
Reporter Occupation: PHARMACIST

Narratives

Description of Event or Problem · 1

PT IS 47 Y/O WOMAN WITH MULTIPLE MYELOMA STAGE IV. PLAN: CYCLE # OF VAD. VINCRISTINE 0.5 MG QD X4D AND DOXORUBICIN 13 MG QD X4D BY CONTINUOUS IV INFUSION VIA HICKMAN CATHETER AND CADD PUMP. DEXAMETHASONE 40 MG PO QD X4. PT LIVES AT NURSING HOME. VISITED ONCOLOGIST WHERE LABS WERE DRAWN AND DECISION WAS MADE TO PROCEED WITH CHEMOTHERAPY CYCLE. AFTER MD WAS OK FOLLOWING REVIEW OF COUNTS AND PHYSICAL EXAM, CHEMO DISPENSED DOXORUBICIN 57 MG AND VINCRISTINE 2.0 MG/96 CC IN NS. IN 100CC CADD CASSETTE ATTACHED TO CADD 5800 PUMP. PUMP WAS PROGRAMMED BY PHARMACIST TO DELIVER 96CC TO 1.0 ML/HR TUBING WAS PRIMED PUMP LOCK LEVEL. PT RETURNED TO FACILITY WITH PUMP TO AWAIT ORDERS FROM MD TO ACTUALLY BEGIN VERBAL ORDERS FROM MD TO BEGIN INFUSION. STAFF RN AT FACILITY ATTEMPTED TO START PUMP AND EXPERIENCED SOME DIFFICULTY IN TURNING THE PUMP ON. SHE ASKED ANOTHER RN FOR HELP IN STARTING THE PUMP AND THIS RN TURNED PUMP ON. 1/2 HR LATER PUMP SIGNAL INFUSION COMPLETE. ERROR NOTED BY THIRD RN. PHARMACIST PROGRAMMED RATE SHOWED 20.0 ML/HR. PUMP IN LOCK LEVEL 1 MD WAS NOTIFIED. PT WAS COMFORTABLE, NADIR COUNTS REVIEWED 13 DAYS LATER, NO OBVIOUS ILL EFFECTS NOTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CADD PCA AMBULATORY INFUSION PUMP	AMBULATORY INFUSION PUMP	FRN	SIMS DELTEC, INC.	CADD-PCA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Other	12/16/97-12/20/97.\| 2 PRIOR CYCLE OF VAD 4/18/97 - 11/22/97.