MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-03 for CADD SOLIS HPCA 2110 21-2111-0300-01 manufactured by Smiths Medical Asd, Inc.
[176118330]
Evaluation results: one cadd-solis hpca was returned for investigation in used condition. The tamper seal was missing and lens were damaged. In addition the dso seal was loose, the battery compartment had some debris and was deformed around the door latch. An accuracy test was performed. The reported customer product problem could not be replicated. No fault was found/ a root cause could not be established.
Patient Sequence No: 1, Text Type: N, H10
[176118331]
It was reported that the pump was over delivering; there was >6% accuracy error. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00133 |
| MDR Report Key | 9548574 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2020-01-03 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH SUITE 100 |
| Manufacturer City | OAKDALE MN 55128 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55128 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD SOLIS HPCA |
| Generic Name | PUMP, INFUSION, PCA |
| Product Code | MEA |
| Date Received | 2020-01-03 |
| Returned To Mfg | 2019-12-30 |
| Model Number | 2110 |
| Catalog Number | 21-2111-0300-01 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |