MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-05-04 for FRESENIUS KABI RED CELL EXCHANGE KIT manufactured by Fresenius Kabi.
[16432856]
Pt receiving redblood cell exchange. Pt became nauseated during treatment. Treatment stopped due to pt becoming pale around mouth and lips and getting very sleepy. Normal saline drip initiated. Dr called to bedside. H and h drawn - result = 2. 8/7. 3. Pt transferred to icu and transfused with 3-4 units prbc. Upon review of machine programming, no deficiencies were noted. Pt examined for internal bleeding, results negative. Unexplained blood loss. Chest wall port examined. No problems found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2598457 |
| MDR Report Key | 2598457 |
| Report Source | 99 |
| Date Received | 2010-05-04 |
| Date of Report | 2010-04-12 |
| Date of Event | 2010-04-06 |
| Date Facility Aware | 2010-04-05 |
| Report Date | 2010-04-12 |
| Date Added to Maude | 2012-06-08 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS KABI RED CELL EXCHANGE KIT |
| Generic Name | RED CELL EXCHANGE KIT |
| Product Code | FLD |
| Date Received | 2010-05-04 |
| Lot Number | C781856 |
| Device Expiration Date | 2012-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS KABI |
| Manufacturer Address | REDMOND WA 98052 US 98052 |
| Brand Name | COMTEC/AS104 |
| Generic Name | AS104 |
| Product Code | FLD |
| Date Received | 2010-05-04 |
| Model Number | AS104/095 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS KABI |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-05-04 |