FDA Adverse Event
Malfunction
Summary report: N
1040
MDR report key: 2257395
·
Received August 26, 2011
Report
- Report Number
- 1219343-2011-00127
- Event Type
- Malfunction
- Date Received
- August 26, 2011
- Date of Event
- June 29, 2011
- Report Date
- August 24, 2011
- Manufacturer
- HAEMONETICS CORP.
- Product Code
- JRQ
- PMA / PMN Number
- BK900026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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 · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1040 | DIGITAL BLOOD SHAKERS | JRQ | HAEMONETICS CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |