MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-31 for CODE CART manufactured by Unk.
[132341644]
Several months ago we had an event in which two drawer 3's were placed in a code cart. Medications are in drawer 1, 2 and 3. Unfortunately this was discovered during a code. Fortunately this unit was close to the pharmacy and could quickly get the correct tray. We had another report this weekend in which the same occurred, but it was caught during and exchange due to product expiration. After the first event, we implemented a double check process when the drawers are placed. Our organization uses kit check and we have been requesting they add functionality to allow scanning the drawer to the correct location in the code cart. We do not have a reliable system to ensure the correct drawers are placed in the correct location of the code cart. (b)(6). Access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082747 |
| MDR Report Key | 8208713 |
| Date Received | 2018-12-31 |
| Date of Report | 2018-12-31 |
| Date Added to Maude | 2019-01-02 |
| 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 | UNKNOWN |
| 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 | 0 |
| Brand Name | CODE CART |
| Generic Name | CORD, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2018-12-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-31 |