MalfunctionJRQ
1040
Received Aug 26, 2011 · Event occurred Jun 29, 2011
Report 1219343-2011-00127 · MDR key 2257395
Device
Generic name
Digital Blood Shakers
Manufacturer
Haemonetics Corp.Model number
NACatalog number
1040-110-US
Lot number
NA
Product problems
- Failure to Reset
Patient
NI
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO HAEMONETICS ON JUNE 30, 2011 AND EVALUATED ON JULY 26, 2011. UPON EVALUATING THE DEVICE THE DEFECT WAS CONFIRMED. UPON REPAIRING THE DEVICE, BLOOD WAS FOUND. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS CONCLUDED.
Description of Event or Problem
A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2011 AND ALLEGED THAT THE DIGITAL BLOOD SHAKERS FAILED QC AND WILL NOT RESET. NO DONOR INJURY WAS REPORTED. NO OPERATOR INJURY WAS REPORTED.