MARS
Received Dec 3, 2021 · Event occurred Nov 7, 2021
Report 3007697864-2021-00002 · MDR key 12925170
Device
Generic name
Apparatus, Hemoperfusion, Sorbent
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
800541
Lot number
0000025311
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
ADDITIONAL INFORMATION: H3, H6 AND H10 H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, FOUR (4) PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION AND THE REPORTED CONDITION WAS VERIFIED. THE CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
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 TREATMENT KIT, A LEAKAGE WAS OBSERVED FROM THE ION EXCHANGER, SPECIFIED AS THE TOP AND BOTTOM OF THE EXCHANGER WHERE IT IS CONNECTED TO THE MIDDLE PART OF THE FILTER. NO VISIBLE CRACKS ON THE FILTER WERE OBSERVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.