InjuryFII
MDR event
Received Mar 14, 2008
Report 9616240-2008-00016 · MDR key 1015182
Device
Product problems
- Unknown (for use when the device problem is not known)
- Defective Component
Patient
Not reported
- Low Blood Pressure/ Hypotension
- Sepsis
- Loss of consciousness
- Therapy/non-surgical treatment, aborted/stopped
- Treatment with medication(s)
- Hospitalization required
Narrative
Additional Manufacturer Narrative
THERE IS NO EVIDENCE TO SUGGEST THAT A GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS PT'S HYPOTENSION OR HER CARDIAC ARREST.