FDA Adverse Event Summary report: N

SMITHS CADD SET 21-7394-24

MDR report key: 12835579 · Received November 17, 2021

Report

Report Number
MW5105425
Date Received
November 17, 2021
Report Date
November 16, 2021
Manufacturer
SMITHS MEDICAL ASD, INC.
Product Code
FRN
Report Source
Voluntary report
Reporter Location
ME, US
Reporter Occupation
501
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PAGE FROM PATIENT CARE GIVER(PCG): SPOKE TO PATIENT'S CAREGIVER WHO REPORTS SHE WENT TO CHANGE HER MOM'S MILRINONE BAG, AND IT WAS COMPLETELY FULL ALTHOUGH THE CADD SOLIS SCREEN READ TIME REMAINING 40 MINUTES. SHE REPORTS THAT HER MOM HAS BEEN OUT OF IT ALL DAY, AND HAD NOT VOIDED AND WANTS TO KNOW IF THIS WAS COMMON THING TO HAPPEN. ADVISED HER TO HOLD ON WHILE THIS RN RETRIEVED A SOLIS PUMP TO ASSIST HER IN REVIEWING THE EVENT LOG. THIS RN WAS AWAY FROM THE PHONE FOR 1 MINUTE. PCG WAS NO LONGER ON THE LINE. CALL BACK TO PCG CELL AND IT RANG AND WENT TO VM. TRIED THE PT'S HOME NUMBER AND SAME THING WENT STRAIGHT TO VM. CALLED BACK PCG NUMBER FOR A 3RD TIME AND REACHED PCG WHO WAS CRYING AND APOLOGIZED THAT SHE WAS ON THE PHONE WITH THE HOSPICE NURSE WHO DID NOT KNOW WHAT TO DO. PCG IS REPORTING B/P LOWER THAN NORMAL 90/50, HR LOWER THAN NORMAL 60'S, FEET ARE COLD AND SHE HAS NOT VOIDED ALL DAY PCG HANDED PHONE OVER TO HER SISTER AND WE CONFIRMED THAT THEY HAD HOOKED HER MOM UP WITH THE BACK UP PUMP SERIAL # (B)(4), CONFIRMED SETTINGS WITH A RES VOL OF 183.5MLS AND CONTINUOUS RATE OF 7.5MLS WE THEN REVIEWED THE NEWER PUMP SERIAL # (B)(4) THAT WAS DELIVERED RECENTLY DUE TO THE OLDER PUMPS LATCH BEING LOOSE. THIS PUMPS RES VOL WAS 2.9MLS WITH A CONTINUOUS RATE OF 7.5MLS. BUT THEY REPORT THIS BAG WAS COMPLETELY FULL. THEY DENY HEARING ANY ALARMS. REVIEW OF THE EVENT LOG DID NOT REVEAL ANY ALARMS. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1723819 SMITHS CADD SET 21-7394-24 SET, ADMINISTRATION, INTRAVASCULAR FRN SMITHS MEDICAL ASD, INC. 21-7394-24 SET LOT 4152748
1723820 SMITHS SOLIS CADD VIP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120

Patients

Seq Age Sex Outcome Treatment
1 71 YR Female