MARS
Received Nov 21, 2021 · Event occurred Oct 28, 2021
Report 3007697864-2021-00001 · MDR key 12849953
Device
Generic name
Apparatus, Hemoperfusion, Sorbent
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
800541
Lot number
ASKU
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H10: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
INITIAL REPORTER: PHONE NUMBER: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT DURING TREATMENT WITH A MARS KIT, A POUT TOO HIGH #04 ALARM WAS TRIGGERED. A FLUID LEAK WAS OBSERVED AT THE TOP OF MARSFLUX DIALYZER AND A AMOUNT OF AIR WAS PRESENT INSIDE THE CIRCUIT. TREATMENT WAS INTERRUPTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.