MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-13 for AT-AUTOTRANSFUSION SET, C.A.T.S. CELL SAVER DISPOSABLE AT1 AUTOTRANSFUSION SET 9005104 manufactured by Freseius Kabi Usa, Llc / Fresenius Hemocare Netherlands B.v..
[175201981]
Malformation in disposable tubing that caused the instrument to display an error code and stop processing. Required defective disposable to be removed from set and replaced to avoid blood loss. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[181383318]
Mdr report key: (b)(4). Report number: mw5092201. The correct lot number is idt182, the catalog number is correct. I mistakenly put the lot number for the reservoir in the report. The mfr is aware of this, and they have the disposable involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092201 |
| MDR Report Key | 9586099 |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-09 |
| Date of Event | 2020-01-07 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AT-AUTOTRANSFUSION SET, C.A.T.S. CELL SAVER DISPOSABLE |
| Generic Name | APPARATUS, AUTOTRANSFUSION |
| Product Code | CAC |
| Date Received | 2020-01-13 |
| Model Number | AT1 AUTOTRANSFUSION SET |
| Catalog Number | 9005104 |
| Lot Number | IDT182 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESEIUS KABI USA, LLC / FRESENIUS HEMOCARE NETHERLANDS B.V. |
| Manufacturer Address | LAKE ZURICH IL 60047 US 60047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-13 |