MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for CADD MS3 GRAY SLATE 7400 21-7411-51 manufactured by Smiths Medical Asd,inc.
[185901885]
Investigation completed on a smith medical cadd ms3 pump. The complaint verified when tested, this was isolated to a loose piece of syringe part was stuck inside the drive rod, which resulted in functional testing error. No information of event in the event log. The device physical appearance was in overall good condition. Unknown what caused event and once the material was released the device passed all functional testing.
Patient Sequence No: 1, Text Type: N, H10
[185901886]
Information received a smiths medical cadd ms3 gray slate pump per medwatch form pump alarming for blockage detected. No delivery and to check tubing. No patient adverse events reported. No further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02435 |
| MDR Report Key | 9908327 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2016-12-22 |
| Date Added to Maude | 2020-03-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 LANE N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH, SUITE 100 |
| Manufacturer City | OAKDALE, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD MS3 GRAY SLATE |
| Generic Name | PUMP, INFUSION |
| Product Code | FRN |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 7400 |
| Catalog Number | 21-7411-51 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD,INC |
| Manufacturer Address | 6000 LANE N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |