MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for EXACTAMIX 500 EVA CONTAINER manufactured by Baxter Healthcare Corporation.
[185480766]
Leaks around the administration port were reported in four exactamx 500 ml bags. The leaking bags were destroyed but all came from the same lot (60189409), exp. Date 04/03/2022. The remaining in the pharmacy from that specific lot were removed and isolated. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093941 |
| MDR Report Key | 9888307 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-23 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | EXACTAMIX 500 EVA CONTAINER |
| Generic Name | SET. I.V. FLUID TRANSFER |
| Product Code | LHI |
| Date Received | 2020-03-26 |
| Lot Number | 60183409 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL US |
| Brand Name | EXACTAMIX 500 EVA CONTAINER |
| Generic Name | SET. I.V. FLUID TRANSFER |
| Product Code | LHI |
| Date Received | 2020-03-26 |
| Lot Number | 60183409 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL US |
| Brand Name | EXACTAMIX 500 EVA CONTAINER |
| Generic Name | SET. I.V. FLUID TRANSFER |
| Product Code | LHI |
| Date Received | 2020-03-26 |
| Lot Number | 60183409 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL US |
| Brand Name | EXACTAMIX 500 EVA CONTAINER |
| Generic Name | SET. I.V. FLUID TRANSFER |
| Product Code | LHI |
| Date Received | 2020-03-26 |
| Lot Number | 60183409 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |