MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-14 for AMBU ACTION PUMP manufactured by Ambu.
[62858235]
Right arthroplasty total knee performed on (b)(6) 2016. Ambulation pump containing 600 ml ropivacaine 0. 2% started at 8 ml at 11:20. Pump was obtained from pharmedium lot 16287045s, and dispensed by our hospital pharmacy. On (b)(6) 2016 at approx 10:15, the pt's nurse noticed on routine check that the pump was empty. Both pa and anesthesiologist verified that pump was empty. Pt's dressing was clean/dry/intact with no leakage noted. Pt did not experience any signs of symptoms of toxicity, but pt was transferred to the imcu for observation given potential gravity of local anesthetic toxicity. No cardiac or neurological signs of toxicity were noted, and pt was discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066762 |
| MDR Report Key | 6185567 |
| Date Received | 2016-12-14 |
| Date of Report | 2016-12-14 |
| Date of Event | 2016-10-25 |
| Date Added to Maude | 2016-12-19 |
| 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 | 0 |
| Brand Name | AMBU ACTION PUMP |
| Generic Name | AMBU ACTION PUMP |
| Product Code | BZK |
| Date Received | 2016-12-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-12-14 |