MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-02 for FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR N/A 9400408 manufactured by Fresenius Hemocare Netherlands B.v..
[188834024]
Patient underload.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807758-2019-00002 |
| MDR Report Key | 9537791 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-06 |
| Date of Event | 2019-12-05 |
| Date Facility Aware | 2019-12-06 |
| Report Date | 2019-12-06 |
| Date Reported to Mfgr | 2019-12-06 |
| Date Mfgr Received | 2019-12-06 |
| Device Manufacturer Date | 2018-05-20 |
| Date Added to Maude | 2020-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. VICKI MCKEE |
| Manufacturer Street | 3 CORPORATE DRIVE |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| Manufacturer Phone | 8475500157 |
| Manufacturer G1 | FRESENIUS HEMOCARE NETHERLANDS B.V. |
| Manufacturer Street | RUNDE ZZ 41 |
| Manufacturer City | EMMER-COMPASCUUM, NL-7881 H |
| Manufacturer Country | NL |
| Manufacturer Postal Code | NL-7881 HM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR |
| Generic Name | COM.TEC PL1 RED CELL / PLASMA EXCHANGE SET |
| Product Code | LKN |
| Date Received | 2020-01-02 |
| Model Number | N/A |
| Catalog Number | 9400408 |
| Lot Number | HET203 |
| Device Availability | N |
| Device Age | 565 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS HEMOCARE NETHERLANDS B.V. |
| Manufacturer Address | RUNDE ZZ 41 EMMER-COMPASCUUM, NL-7881 H NL NL-7881 HM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-02 |