MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for SAPPHIREPLUS 15038 manufactured by Q Core Medical.
[131373356]
Infusion pump programmed at 8. 8ml/hr of d10, with max volume to infuse of 17. 6 ml, noted jittery baby, hyperglycemia, and ml missing from bag. No alarm. Diagnosis or reason for use: maintenance fluid. Two rns working with pt state no unusual event occurred when iv bag hung. Interrogation of pump shows record that pump was set correctly. Pt required transfer to higher level of care nicu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8189486 |
| MDR Report Key | 8189486 |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-12-04 |
| Date Facility Aware | 2018-12-05 |
| Report Date | 2018-12-13 |
| Date Reported to Mfgr | 2018-12-11 |
| Date Added to Maude | 2018-12-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | SAPPHIREPLUS |
| Generic Name | SAPPHIREPLUS |
| Product Code | MRZ |
| Date Received | 2018-12-21 |
| Model Number | 15038 |
| Device Expiration Date | 2019-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | Q CORE MEDICAL |
| Manufacturer Address | 29 YAD HARUZIM ST. PO BOX 8639 NETANYA 4250529 IS 4250529 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2018-12-21 |