InjuryFII
MDR event
Received May 27, 2008
Report 9616240-2008-00030 · MDR key 1057122
Device
Product problems
- Normal
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Headache
- Nausea
- Seizures
- Seizures, Grand-Mal
- Cramp(s)
- Electrolyte Imbalance
- Therapy/non-surgical treatment, additional
- Blood pressure, decreased
- Treatment with medication(s)
- Hospitalization required
Narrative
Additional Manufacturer Narrative
ON 4/14/08 THE HOSP'S BIOMEDICAL TECH RECALIBRATED THE FINAL CONDUCTIVITY, PERFORMED A PA AUTOCALIBRATION AND A T1 TEST. A GAMBRO TECH INSPECTED THE PHOENIX MACHINE ON 4/22/08. ALL THE PARAMETERS WERE WITHIN MFR'S SPECS. FROM THE AVAILABLE DATA IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE THAT LED TO THE REPORTED EVENT. A TECHNICAL INVESTIGATION IS IN PROGRESS AT GAMBRO DASCO. SHOULD SIGNIFICANT NEW INFO BECOME AVAILABLE A FOLLOW-UP MDR WIL BE SUBMITTED.