InjuryJQQ
FRESENIUS OPTIFLUX F180 NRE DIALYZER
Received Jan 22, 2015 · Event occurred Oct 23, 2014
Report 4487304 · MDR key 4487304
Device
Product problems
- Patient-Device Incompatibility
Patient
76 YR
- Cardiopulmonary Arrest
- Anaphylactoid / Anaphylaxis
Narrative
Description of Event or Problem
ON (B)(6) 2014, PT PRESENTED TO FACILITY FOR FIRST OUTPATIENT TREATMENT. PRE-TX VITAL SIGNS STABLE. DIALYSIS INITIATED 6:32 AM. BLOOD PRESSURE 122/74 AND PULSE 72. AT 6:35 AM PT COMPLAINED OF FEELING DIZZY AND THEN BECAME UNRESPONSIVE. PT WAS WITHOUT PULSE OR RESPIRATIONS. CPR INITIATED AND CONTINUED UNTIL EMS ARRIVED AT 6:45 AM. EMS TOOK OVER PT CARE. PT TRANSPORTED TO THE HOSP. PT CURRENTLY IN THE HOSP, STILL UNDER EVAL.