MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-23 for CADD-SOLIS HPCA PIB PUMP 21-2111-0100-51 2110 manufactured by Smiths Medical Asd, Inc..
[184632366]
Information was received indicating that a smiths medical cadd solis pump was implicated in a leaking issue. During administration of blinatumomab, a puddle of liquid on the floor was found during the infusion. They checked over the tubing but couldn't find an apparent leak. It should be noted that another iv bag with different tubing was also infusion at the time, so it couldn't definitely be linked to leaking tubing from the cadd administration set. No adverse events were reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02179 |
| MDR Report Key | 9869664 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2010-11-20 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD-SOLIS HPCA PIB PUMP |
| Generic Name | PUMP, INFUSION, PCA |
| Product Code | MEA |
| Date Received | 2020-03-23 |
| Model Number | 21-2111-0100-51 |
| Catalog Number | 2110 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |