FDA Adverse Event Injury Summary report: N

INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED

MDR report key: 18204649 · Received November 22, 2023

Report

Report Number
MW5148428
Event Type
Injury
Date Received
November 22, 2023
Report Date
November 20, 2023
Manufacturer
DEKA RESEARCH & DEVELOPMENT CORP.
Product Code
QJY
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

PER CNSS COMMUNICATION: "ADVERSE EVENT EXPERIENCED: HOSPITAL ADMISSION, HEADACHE, DIZZINESS, NAUSEA, DIARRHEA, INCREASED SHORTNESS OF BREATH, DEFECTIVE PUMPS/ REMOTES. DESCRIPTION OF EVENT: PT WAS RECENTLY ADMITTED AFTER 2 BLOOD TRANSFUSIONS FOR SEVERE PROLONG MENSTRUAL BLEEDING. SHE EXPERIENCED HEADACHE, DIZZINESS, NAUSEA, AND DIARRHEA DURING HOSPITALIZATION BUT THEY HAVE SINCE RESOLVED. SHE NOW COMPLAINS OF INCREASED SHORTNESS OF BREATH WITH EXERTION AND AT REST. PT HAS ALSO HAD SEVERAL PUMPS/ REMOTES "GO BAD", AND CNSS WAS ASKED TO ASSESS. ADVERSE EVENT RESOLUTION DATE: ONGOING SHORTNESS OF BREATH. PT REPORTS HAVING BACKUP PUMP AND REMOTE STOP WORKING PROPERLY AND PHARMACY SENT A NEW KIT. THIS HAPPENED AGAIN A SHORT TIME LATER, SO THEY HAVE SENT ANOTHER NEW KIT AND HAVE REQUESTED CNSS SUPPORT. I HELPED PT TODAY WITH PUMP REMOTE SET UP AND OBSERVED HER DOING A CASSETTE CHANGE. I DID NOT OBSERVED ANY CONCERNS WITH PT AND, SHE REMAINS 100% INDEPENDENT. THERAPY INTERRUPTION REPORTED. NO FURTHER INFO, DETAILS OR DATES AVAILABLE, AS THE SUSPECT DEVICE SERIAL NUMBER WAS NOT REPORTED. IT IS UNK WHICH DEVICE IS MALFUNCTIONING. PER PHARMACY DISPENSING SYSTEM, THE FOLLOWING SERIAL NUMBERS ARE CURRENTLY CHECKED OUT TO PT FOR USE: (B)(6). THE MAINTENANCE DUE DATES ARE UNK SQ REMUNITY SELF-FILL PT. I ASSESSED BACKUP PUMP/REMOTE AND FOUND CASSETTE AND PUMP TO BE STUCK TOGETHER AND UNABLE TO ROTATE. PT DENIES ANY INFUSION PROBLEMS. THEY ARE BEING SENT BACK WITH CASSETTE IN PLACE TO BE ASSESSED. I CONFIRMED PT HAS 2 WORKING PUMPS / REMOTES. PT REPORTS INCREASED SHORTNESS OF BREATH WITH EXERTION AND REST. SHE HAS NOT INCREASED DOSE IN A FEW MONTHS BUT SAYS THAT MD OFFICE IS AWARE OF THIS AND HAS TOLD HER NOT TO INCREASE DOSE RIGHT NOW. I AM SUGGESTING TO THE MD OFFICE THAT THIS BE REASSESSED. CNSS NOTIFIED MD OFFICE. ONSET DATES, OF ALL EVENTS IS UNK. CARE OF ADMITTANCE / DISCHARGE OR LENGTH OF HOSPITALIZATION IS UNK. MALFUNCTIONING PUMP / REMOTES ARE AVAILABLE FOR RETURN. NO ADVERSE EVENTS. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL. REFER REPORT: MW5148429.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1498168 INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY DEKA RESEARCH & DEVELOPMENT CORP.

Patients

Seq Age Sex Outcome Treatment
1 Female Hospitalization AMBRISENTAN| REMODULIN MDV| REMTY WNTY REPLMT PUMP KIT