FDA Adverse Event Death Summary report: N

CADD-PCA INFUSION PUMP

MDR report key: 2017 · Received January 5, 1993

Report

Report Number
2017
Event Type
Death
Date Received
January 5, 1993
Date of Event
December 8, 1992
Manufacturer
PHARMACIA DELTEC INC.
Product Code
MEA
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

1630 12/7/92 PHARMACIST FILLED DOCTOR'S ORDER FOR PUMP: WRITTEN DOSING GUIDELINES .5MG/DOSE 10 MIN LOCKOUT=6 DOSE PER HOUR. .5MG/DOSE X 6 = 3MG EACH HOUR. 3MG/30KG = 0.1 MG/KG/HR. NURSE EXPLIANED TO MOTHER THAT PATIENT COULD RECEIVE A DOSE EVERY 10 MINUTES IF BLUE BUTTON PUSHED. MOTHER APPEARED TO UNDERSTAND, PATIENT VERBALIZED TO THE NURSE AND PHARMACIST THAT HE COULD PUSH IT AS INSTRUCTED. AT 2315 PHARMACIST REVIEWED THE PUMP FLOW SHEET WHICH INDICATED THE FOLLOWING. 29ML REMAINING (50ML-29ML =21 ML USED); FROM 1715-2315 (6 HOURS) 21 MG USED. IF MAX DOSE DELIVERED SHOULD HAVE BEEN 18 MG. 16% ERRORR (AT 21 MG/6 HOUR=0.116 MG/KG/HR IS STILL WITHIN GUIDELINES). AT 0830 12/8/92 THE PHAMACIST WAS NOTIFIED BY THE ICU PHARMACIST THAT PATIENT HAD CODED AT 0500 THAT MORNING. UNKNOWN WHEN PUMP STOPPED OR DISCONNECTED (ASSUMED AT TIME OF CODE 0500). PUMP RETURNED TO PHARMACY SHOWING 6 ML LEFT - IV'S COUNTED 3+ ML WITH SOME LOST IN TUBING, PRIMING.. IV REFRACTIVE INDEX 1.2 CONSISTENT WITH MORPHINE IF 44MG DELIVERED FROM 1715 TO 0500 (12 HOURS) 44MG/12 HR =3.67 MG/30KG=.122 MG/KGHR OR .244 MG/KG EVERY 2 HOURS IS UPPER DOSING LIMITSDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CADD-PCA INFUSION PUMP INFUSION PUMP MEA PHARMACIA DELTEC INC. 5800

Patients

Seq Age Sex Outcome Treatment
1 6 YR Death