MARS
Received May 19, 2020 · Event occurred Apr 28, 2020
Report 3007697864-2020-00001 · MDR key 10071347
Device
Generic name
Mars Kit Gambro Type 1112/1
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
800473
Lot number
0000024589
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
D4: EXPIRATION DATE ADDED. H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, TWO PHOTOS OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE PHOTOS DID NOT REVEAL THE EXACT LOCATION OF THE LEAK. THE REPORTED CONDITION WAS NOT VERIFIED DUE TO THE LACK OF ACTUAL SAMPLE, FURTHER INVESTIGATION WAS NOT POSSIBLE. 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
(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT UPON INITIATION OF THERAPY WITH A MARS KIT, AN EXTERNAL BLOOD LEAK WAS OBSERVED AT THE TOP OF THE FILTER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.