MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-06 for CDS830177J manufactured by Baxter International Inc..
[99101576]
It was reported that the patient received the wrong intravenous fluid infusion. The patient received plasma-lyte a instead of lactated ringers. Per the facility, the fluids were not inspected or scanned prior to administration. The incorrect fluid was noticed by the nurse in the middle of the infusion after the patient received 300 ml of plasma-lyte a. The infusion was discontinued and the physician was notified. There was no reported injury or follow-up medical care. There was no reported impact to the patient or impact to the procedure being performed. The sample was discarded and is not available to be returned to the manufacturer for evaluation. The initial manufacturer was notified of the event. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[99101577]
It was reported that the patient received the wrong intravenous fluid infusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00004 |
| MDR Report Key | 7243886 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-06 |
| Date of Report | 2018-02-06 |
| Date of Event | 2018-02-02 |
| Date Mfgr Received | 2018-02-02 |
| Date Added to Maude | 2018-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LABOR CDS |
| Product Code | MLS |
| Date Received | 2018-02-06 |
| Catalog Number | CDS830177J |
| Lot Number | 17ZB4005 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER INTERNATIONAL INC. |
| Manufacturer Address | ONE BAXTER PARKWAY DEERFIELD IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-06 |