inforMED
MalfunctionBYP

VOLUMATIC

Received Sep 14, 1998

Report 1033964-1998-00001 · MDR key 187444

Device

Generic name

Aerosol Expansion Chamber Device For Metered-dose Inhalers

Model number

K844169

Catalog number

*

Lot number

*

Patient

*

  • Chest Pain
  • Breathing difficulties
  • Sweating

Narrative

Description of Event or Problem

PHARMACIST INITIALLY REPORTED THAT FEMALE PT WITH HISTORY OF MITRAL VALVE PROLAPSE, PANCREATIC DAMAGE, HIATUS HERNIA AND STOMACH ULCERS RECEIVED INHALED BECLOMETHASONE DIPROPIONATE (BECOTIDE) 100MCG (BDP). PT HERSELF REPORTED THAT SHE HAD USED BDP FOR 5 YRS, BUT HAD RECENTLY STARTED USING VOLUMATIC SPACER DEVICE FURTHER TO DIAGNOSIS OF CANDIDIASIS OF THE THROAT FOR WHICH SHE WAS ALSO RECEIVING NYSTATIN. EACH OF THREE TIMES SHE USED SPACER, SHE DEVELOPED SHARP CHEST PAINS, SWEATING AND HAD DIFFICULTY BREATHING IN THROUGH SPACER. SYMPTOMS LASTED ABOUT 20 MINUTES AND SHE DEALT WITH SYMPTOMS BY SITTING QUIETLY EVENTS WERE REPORTED INITIALLY BY PHARMACIST AS RESEMBLING HEART ATTACK OCCURRING ONE HR AFTER USE OF INHALER PLUS SPACER AND LASTING THREE HRS. ALTHOUGH PHARMACIST REPORTED PT HAD BEEN HOSPITALISED (AND THAT EVENTS WERE LIFE-THREATENING), PT CONFIRMED SHE HAD NOT BEEN HOSPITALIZED. PT SAID SHE DOES NOT EXPERIENCE EVENTS WHEN SHE DOES NOT USE SPACER HOWEVER, PAINS RECUR WHEN SHE DOES USE SPACER. INFO WAS ALSO RECEIVED VIA THERAPEUTIC GOOD AGENCY WHO REPORTED EVENT AS INCIDENT THAT WAS ASSOCIATED WITH USE OF VOLUMATIC. PT WAS NOTED TO HAVE HAD DIFFICULTY BREATHING DURING EVENTS, AND THAT SHE NEEDED TO 'BREATH EXTRA-HARD TO GET REQUIRED MEDICATION - DIFFICULT TO USE'. WITHOUT VOLUMATIC, FEW CHEST PAINS WERE EXPERIENCED.

Remedial action

  • Patient Monitoring