MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-09 for LEVCOREDUCTION FILTER KSV0002XD manufactured by Macoproductions S.a.s..
[37724961]
No. 133900 filter similar products sold in (b)(6) without any complaint about leak. Potential contamination very low. Investigation still ongoing at this date.
Patient Sequence No: 1, Text Type: N, H10
[37724962]
Loss of integrity of the filter during filtration. Blood leaked from filter. Filtration condition: blood storage 1 degree before filtration 22 celsius. Blood storage time before filtration 5 hours. Filtration 1 degree - 22 celsius. Filtration time; approx. 6mm. Blood center: gulf coast. Duration number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710488-2004-00001 |
| MDR Report Key | 5404929 |
| Date Received | 2004-07-09 |
| Date of Report | 2004-07-09 |
| Date of Event | 2004-05-20 |
| Date Mfgr Received | 2004-06-01 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2016-02-02 |
| 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 | FRANCIS GOUDALIEZ |
| Manufacturer City | RUE LORTHIOIS MOUVAUX 59420 |
| Manufacturer Country | FR |
| Manufacturer Postal | 59420 |
| Manufacturer Phone | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LEVCOREDUCTION FILTER |
| Generic Name | MEDICAL DEVICE |
| Product Code | MAC |
| Date Received | 2004-07-09 |
| Model Number | KSV0002XD |
| Lot Number | 284803G22 |
| Device Expiration Date | 2005-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MACOPRODUCTIONS S.A.S. |
| Manufacturer Address | TOURCOING 59420 FR 59420 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-07-09 |