MDR event
Received Sep 29, 2006
Report 1713747-2006-00220 · MDR key 768351
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Hemolysis
- Skin Discoloration
- Electrolyte Imbalance
- Other (for use when an appropriate patient code cannot be identified)
- Transfusion of blood products
- Resuscitation
- Abdominal Cramps
- Blood pressure, increased
Narrative
Description of Event or Problem
REC'D MEDWATCH REPORT FROM A HEMODIALYSIS USER FACILITY IN THE MAIL. IT HAS BEEN REPORTED THAT A PT REC'D A HEMODIALYSIS TREATMENT. AFTER PT WAS DISCHARGED AND TRANSFERRED TO THEIR UNIT, THEIR CONDITION WORSENED. THE PT WAS THEN TRANSFERRED TO ICU. WORKUP OF THE PT HGB HAD DROPPED FORM 11.0 TO 4.4. THE PT DID RECEIVE 2 UNITS OF PRBC. THE INITIAL REPORTER OF THIS EVENT WAS CONTACTED AND VERBALLY REPORTED WAS "THIS PT WAS NOT TERRIBLY ILL. THIS DIALYSIS PT COMPLETED DIALYSIS AND BECAME ILL. IT WAS A CASE OF HEMOLYSIS. A CODE WAS CALLED BECAUSE THE STAFF THOUGH THAT THE PT MAY ARREST. BLOOD WAS DRAWN AND WAS EXTREMELY HEMOLYZED AND IT LOOKED BLACK. THE SYMPTOMS THIS PT EXPERIENCED FROM THIS EVENT WERE ABDOMEN CRAMPING DURING DIALYSIS, A FEELING TO DEFICATE, AN INCREASED BP, AND THE PT WAS NOTED TO TURN DARK, LIKE A SUNTAN ALTHOUGH THE RN, WHO WAS THE DIRECT CAREGIVER THOUGH THAT THE PT DID NOT LOOK PALE". THE PT RESPONDED TO THE INTERVENTIONS AND RECOVERED FROM THIS INCIDENT. THE RN ALSO STATED THAT THE FACILITY HAS PERFORMED AN EXTENSIVE INVESTIGATION AS A RESULT OF THIS EVENT. SHE VERBALLY STATED " NEVER THOUGHT IT WAS THE DIALYZER, NEVER A QUESTION THIS WAS A DIALYZER".