ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT
Received Nov 5, 2015 · Event occurred Dec 17, 2012
Report 1722554-2015-31261 · MDR key 5205265
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
49 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).
Description of Event or Problem
IT WAS REPORTED THAT ABVISER INSERTED TO A TRAUMA PATIENT, POST SPLENECTOMY. READINGS DISPLAYED VARIED CONSIDERABLY FROM THOSE OBTAINED PRIOR TO INSERTION; FROM TEENS DOWN TO 3. THEY TRIED TROUBLESHOOTING AND ULTIMATELY IN LESS THAN 24 HOURS REMOVED IT AND INSERTED ANOTHER ABVISER; THEY FELT READINGS WERE MORE ALIGNED WITH THEIR EXPECTATIONS. THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM ICU; NO FOLLOW UP INFO IS AVAILABLE FROM THAT POINT.