FDA Adverse Event Malfunction Summary report: N

GRASEBY MEDICAL

MDR report key: 318884 · Received February 20, 2001

Report

Report Number
318884
Event Type
Malfunction
Date Received
February 20, 2001
Report Date
February 14, 2001
Manufacturer
MARCAL MEDICAL INC
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THIS EVENT IS OF A "NEAR MISS" NATURE; THERE WAS NO PT INJURY. A SYRINGE PUMP WAS SUSPECTED OF INFUSING A DOSE OF PERSANTINE AT AN INCORRECT RATE (TOO FAST). THE SYRINGE PUMP WAS TAKEN OUT OF SERVICE AND SENT TO THE MFR. THE DEVICE HISTORY REVEALED THAT THE PUMP WAS SENT TO THE MFR IN 11/2000 TO REPAIR A BROKEN SYRINGE SIZE SENSOR AT THE MFR'S REQUEST. THE MFR MAINTAINED THAT TO MEET THEIR QUALITY STANDARDS, THE PUMP HAD TO BE SERVICED BY THEM. IT WAS RETURNED TO THE HOSPITAL ON THE NEXT DAY. FOUR DAYS LATER THE PUMP WAS AGAIN TAKEN OUT OF SERVICE AND AGAIN SENT BACK TO THE MFR FOR REPAIR (RECALIBRATION). IT WAS RETURNED TO THE HOSPITAL IN 12/2000 AND WAS PUT INTO USE. IT WAS FINALLY TAKEN OUT OF USE TWO DAYS LATER WHEN IT WAS SUSPECTED THAT AN INFUSION OF PERSANTINE IN A 30CC SYRINGE, WHICH SHOULD HAVE INFUSED OVER FOUR MINUTES, INFUSED IN LESS TIME. IN 01/2001, HOSPITAL'S CLINICAL ENGINEERING DEPT CONDUCTED A TEST OF THE PUMP WITH TELEPHONE SUPPORT BY MARCAL MEDICAL. THE SYRINGE SIZE INCORRECTLY IDENTIFIED SYRINGE SIZE(S). IT WAS DETERMINED IN THE TEST SITUATION THAT THE SYRINGE SIZE SENSOR INCORRECTLY IDENTIFIED A 30CC SYRINGE AS A 20CC SYRINGE, WHICH CAUSED THE CLIP TO INCORRECTLY IDENTIFY THE SYRINGE SIZE. THIS WAS THE PRIMARY CAUSE OF THE DEVICE FAILURE. THE 30CC SYRINGE INFUSED AT A 20CC SYRINGE RATE. THE PUMP WAS SENT TO THE MFR YET AGAIN, AND THE CORRECTION WAS MADE. UPON RETURN OF THE PUMP, TESTING BY CLINICAL ENGINEERING AND EVALUATION BY THE NURSING UNIT VERIFIED PROPER AUTHORIZATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
6619 GRASEBY MEDICAL SYRINGE PUMP FRN MARCAL MEDICAL INC 3400 NA

Patients

Seq Age Sex Outcome Treatment
1 * Other