MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-08 for PCA 7.01 W/ MEDNET 208370401 manufactured by Icu Medical Costa Rica Ltd..
[167018649]
The device is available for investigation. It has not been received.
Patient Sequence No: 1, Text Type: N, H10
[167018650]
The event involved a lifecare pca pump that the customer reported the pump overdosed and pushed too much of an unspecified medication to the patient. There was patient involvement, however there was no adverse event and no delay in critical therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2019-00449 |
| MDR Report Key | 9297606 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-08 |
| Date of Report | 2019-10-16 |
| Date of Event | 2019-10-15 |
| Date Mfgr Received | 2019-10-16 |
| Device Manufacturer Date | 2016-10-20 |
| Date Added to Maude | 2019-11-08 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTOPHER ZANONI |
| Manufacturer Street | 600 N. FIELD DR. |
| Manufacturer City | LAKE FOREST IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 2247062300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PCA 7.01 W/ MEDNET |
| Generic Name | PUMP, INFUSION, PCA |
| Product Code | MEA |
| Date Received | 2019-11-08 |
| Catalog Number | 208370401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-08 |