FDA Adverse Event Injury Summary report: N

CASSETTE MEDI RESERVOIR

MDR report key: 14776563 · Received June 21, 2022

Report

Report Number
MW5110430
Event Type
Injury
Date Received
June 21, 2022
Report Date
June 16, 2022
Manufacturer
SMITHS MEDICAL ASD, INC.
Product Code
LHI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT REPORTED THAT HER PUMP STOPPED WORKING AND PRODUCED A CONSTANT BEEPING SOUND. WHEN ASKED WHAT ALARM CODE DISPLAYED ON HER PUMP, SHE REPLIED, NO DISPOSABLE, PUMP WONT RUN. ON BOTH PUMPS. RELAYED TO PATIENT THAT THIS CODE REFERS TO A MISALIGNED/LOOSE CASSETTE. PATIENT WAS ADAMANT THAT SHE PLACED THE CARTRIDGE IN CORRECTLY AND AFTER A COUPLE MINUTES OF FRUSTRATED TINKERING OF HER PUMP, ON-CALL NURSE (B)(6) EXPLAINED THAT SHE WASN'T FEELING VERY GOOD BECAUSE SHE HAD BEEN OFF HER MEDICATION FOR ABOUT HALF HOUR NURSE ATTEMPTED TO TRY AND HELP PATIENT WITH THE CASSETTE ISSUE BUT PATIENT STATED SHE WENT BACK TO HER OLD PUMP. PATIENT REVEALED THAT SHE WAS TRANSFERRED TO CVS WITHOUT PRIOR KNOWLEDGE AND NO TEACH SESSION WAS GIVEN. NURSE ASSURED PATIENT THAT SHE WOULD CALL PATIENT AT HER NEXT CASSETTE CHANGE ((B)(6) 2022 AT 18:00) AND HAVE ANOTHER NURSE SENT TO HER RESIDENCE SO A PROPER TEACH SESSION COULD BE GIVEN. NO MORE INFO AVAILABLE. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? YES; PT STARTED TO FEEL UNWELL BECAUSE WAS OFF MEDICATION FOR HALF HOUR, IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? NO; IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? NO; WE WILL SEND NURSE, DID WE REPLACE THE CASSETTE? NO; DID THE PT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? NO; IF NO, WHAT WAS THE PT INSTRUCTED TO DO IN ABLE TO CONTINUE THEIR INFUSION? OLD PUMP. IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO CVS/CAREMARK BY PT/CAREGIVER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
256870 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. UNK
256871 PUMP CADD LEGACY PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.

Patients

Seq Age Sex Outcome Treatment
1 Female