MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-08-26 for 1040 1040-110-US manufactured by Haemonetics Corp..
[16726612]
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.
Patient Sequence No: 1, Text Type: D, B5
[16938638]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219343-2011-00127 |
| MDR Report Key | 2257395 |
| Report Source | 06 |
| Date Received | 2011-08-26 |
| Date of Report | 2011-08-24 |
| Date of Event | 2011-06-29 |
| Date Mfgr Received | 2011-06-29 |
| Date Added to Maude | 2012-01-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW SAGENDORPH |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7813569619 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1040 |
| Generic Name | DIGITAL BLOOD SHAKERS |
| Product Code | JRQ |
| Date Received | 2011-08-26 |
| Returned To Mfg | 2011-06-30 |
| Model Number | NA |
| Catalog Number | 1040-110-US |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORP. |
| Manufacturer Address | 400 WOOD RD BRAINTREE MA 02184 US 02184 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-26 |