FDA Adverse Event Malfunction Summary report: N

AVANOS

MDR report key: 18695510 · Received February 13, 2024

Report

Report Number
18695510
Event Type
Malfunction
Date Received
February 13, 2024
Date of Event
December 19, 2023
Report Date
December 27, 2023
Manufacturer
AVANOS MEDICAL, INC.
Product Code
KNT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

SITUATION: PATIENT WITH NEW ONSET TACHYCARDIA UP TO 180-190S WHILE CALM, OCCASIONALLY INTO THE 200'S (MAX HEART RATE 210), WHO INITIATED THE RRT (RAPID RESPONSE TEAM). BACKGROUND: 22 MONTHS-OLD MALE ADMITTED WITH RESPIRATORY SYNCYTIAL (RSV) BRONCHIOLITIS AND EAT (ECTOPIC ATRIAL TACHYCARDIA). NASOJEJUNAL TUBE (NJ) IN PLACE FOR MEDS AND FEEDS. ASSESSMENT: PATIENT BASELINE HR 110'S-120'S WHILE IN PEDIATRIC INTENSIVE CARE UNIT (PICU) AND INITIALLY DURING FIRST 10-15 ON UNIT, ABRUPT INCREASE WITH PERSISTENT HR > 180. PATIENT ALSO ON ENTERAL FEEDS WHERE NJ WAS NOTED TO BE TAPED DUE TO BROKEN/LOOSE CONNECTION AND UPON ASSESSMENT WAS LEAKING FEEDS AND LIKELY MEDICATION. LAST DOCUMENTED DOSE OF SOTALOL WAS [TIME REDACTED] IN PICU PRIOR TO PATIENT TRANSFERRING TO PCU 300. THIS DOSE OF SOTALOL LIKELY NEVER REACHED THE PATIENT DUE TO MALFUNCTIONING TUBE, LEADING TO ECTOPIC ATRIAL TACHYCARDIA (EAT). REGISTERED RESPIRATORY THERAPIST (RRT) CALLED WITHIN 5 MINUTES OF RSN BEING CALLED TO ROOM BY BEDSIDE RN AND RSN IDENTIFYING EAT. REQUESTED A STAT EKG AND IVF. RECOMMENDATION: TRANSFER TO ICU TO RESOLVE EAT WITH EITHER IV MEDICATION OR PLACEMENT OF NEW NJT AND NJ SOTALOL ADMINISTRATION. AFTER REVIEW WITH THE BEDSIDE, RN LEARNED THE SIDE PORT OF THE NJ TUBE HAD TAPE ON IT. ONCE MEDICATION ADMINISTERED ON PCU 300 NOTED VISCOSITY OF MEDICATION AND IF THIS CONTRIBUTED TO THE TUBE SIDE PORT DISINTEGRATING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
792933 AVANOS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. 40-9438 30274486

Patients

Seq Age Sex Outcome Treatment
1 12 MO Male