inforMED
InjuryFJG

AN-69

Received Jul 31, 1999

Report 8010182-1999-00017 · MDR key 233895

Device

Generic name

Dialyzer

Manufacturer

Hospal Industrie

Model number

FIL-20

Catalog number

FIL-20

Lot number

UNK

Product problems

  • Reaction

Patient

UNKNOWN

  • Low Blood Pressure/ Hypotension
  • Therapy/non-surgical treatment, additional
  • Therapy/non-surgical treatment/delayed/prolonged
  • Treatment with medication(s)

Narrative

Description of Event or Problem

CUSTOMER REPORTED A SEVERE DROP IN PT BLOOD PRESSURE IMMEDIATELY UPON INITIATING THE TREATMENT WITH AN AN69 FILTER IN AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT WITH BLOOD PRIME. ONCE THE BLOOD PRESSURE WAS STABILIZED, EITHER WITH MEDICATION OR VOLUME BOLUSES, THE TREATMENT RESUMED WITHOUT FURTHER INCIDENT.

Remedial action

  • Other