FDA Adverse Event Malfunction Summary report: N

BARD AMBULATORY PCA PUMP

MDR report key: 4141 · Received July 20, 1992

Report

Report Number
4141
Event Type
Malfunction
Date Received
July 20, 1992
Date of Event
March 15, 1992
Report Date
April 10, 1992
Manufacturer
BARD BARD AMBULATORY PCA PUMP
Product Code
MEA
Product Problem
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

MORPHINE SULFATE VIA PCA PUMP INITIATED. 1:1 CONCENTRATION. BASAL RATE 1.5 MG/HR. PATIENT DOSE 1 MG Q. 20 MINUTES. 1 HOUR LIMIT - 4.5 MG. PUMP CHECJKED AT 8:00 A.M. SETTINGS CONFIRMED. 58 CC HAD THUS FAR INFUSED. PUMP DSCONTINUED AT 10:30 A.M. NOTED THAT PUMP WAS PLACED IN VINYL BAG BACKWARDS AND SREEN SHOWED CODE 000. BAG WAS EMPTY. PATIENT HAD RECEIVED 42 MG IN 2.5 HOURS. PATIENT OBSERVED AND DISCHARGED. NO DETERIORATION IN PATIENT'S CONDITION. NURSE WHO CHECKED THE PUMP AT 8 A.M. CONFIRMED THAT TJE BAG WAS FACING FRONT OF WINDOW. IT IS SUSPECTED THAT THE PATIENT TAMPERED WITH THE PUMPS. BARD AMBULAORY PCA PUMP TUBING AND BARD PCA ANTI REFLUX TUBING ALSO IN USEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-SEP-91. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.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, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BARD AMBULATORY PCA PUMP PATIENT CONTROLLED ANALGESIA PUMP MEA BARD BARD AMBULATORY PCA PUMP 6464202 N/A

Patients

Seq Age Sex Outcome Treatment
1 40 YR Other