FDA Adverse Event Injury Summary report: N

CADD LEGACY PUMP

MDR report key: 14800854 · Received June 23, 2022

Report

Report Number
MW5110483
Event Type
Injury
Date Received
June 23, 2022
Report Date
June 20, 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

SPONTANEOUS. RPH (B)(6) AT (B)(6) HOSPITAL REQUESTING PT'S IV TREPROSTINIL DOSING INFO. PER RPH PT'S PUMP HAS BEEN OFF FOR 4 HOURS DUE TO UNSPECIFIED MALFUNCTION; PHARMACY NOT NOTIFIED BEFORE THIS CONTACT. BOTH PUMPS [SN (B)(4) , MAINTENANCE DUE 09/22/2022 AND SN (B)(4) MAINTENANCE DUE 09/21/2022] DISPLAYED "NO DISPOSABLE" ALARM; PUMP COULDN'T READ CASSETTE. PT IS CURRENTLY IN THE ER WAITING TO RESTART INFUSION. RPH UNSURE IF THEY WILL BE ADMITTING PT OR IF THEY WILL BE ABLE TO ASSIST WITH THE PUMP ISSUE AND SEND PT HOME. UNKNOWN IF THIS IS A PUMP OR CASSETTE ISSUE. CASSETTE LOT NUMBER UNKNOWN. MD NOTIFIED. REQUESTED HOSPITAL RPH INSTRUCT PT TO CALL PHARMACY TO REPLACE PUMPS IF NEEDED; PUMPS NOT REPLACED AT THIS TIME. PUMP RETURN TRACKING INFO IS NOT AVAILABLE. PHOTOGRAPHS NOT PROVIDED. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF THE PUMP WHEN ALARM OCCURRED IS UNKNOWN. 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? NONE REPORTED. IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? NO; DID WE [MFR] REPLACE THE CASSETTE? NO; DID THE PT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? NO; IF NO, WHAT WAS THE PT INSTRUCTED TO DO IN ABLE TO CONTINUE THEIR INFUSION? WENT TO ER; IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? ONGOING. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
608903 CADD LEGACY PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC. 6400 UNK
608904 CADD LEGACY PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.
608905 CASSETTE SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.

Patients

Seq Age Sex Outcome Treatment
1 Female