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 2019-01-08 for NDEHP SAPPHIRE + PBKSET 2CLV 1638502 163850455 manufactured by Icu Medical Costa Rica Ltd..
[132364935]
It is unknown if the device is available for investigation.
Patient Sequence No: 1, Text Type: N, H10
[132364936]
The event involved a customer allegation of a patient scheduled to receive dextrose 10% with electrolytes at 18mm, but went a little over 200mm via sapphire primary piggyback set 2 clave y-site, 120 inch on (b)(6) 2018. Dextrose 10% with electrolytes was discontinued, a pediatric endocrinologist was consulted and iv regular insulin 0. 15 units/kg was given stat to treat a glucose of 1834. The patient? S glucose decreased to 534 and another dose of regular insulin 0. 15 units/kg was given stat. After 30 minutes, the glucose decreased to 314. The patient was transferred to the regional pediatric hospital for further endocrine assessment. It was mentioned that the priming method used was with the pump and approximately 20 ml of volume was used for priming. Initially, the volume of the bag was 515 ml and approximately 375 ml was left in the bag with a vtbi difference of 140 ml. The pump was placed in a cradle accessory during the treatment. It was also reported that the pump did not alarm at the beginning, during, or the end of the treatment. It was also reported that the pump never alarmed. The nurses checked the pump with 6 seconds left when pump was stopped. The pump read that 17. 6 ml infused over the last 2 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2019-00001 |
| MDR Report Key | 8226471 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-08 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2019-05-19 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-01-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMILY ARNOULD, BSN, RN |
| 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 | NDEHP SAPPHIRE + PBKSET 2CLV |
| Generic Name | ADMINISTRATION SET |
| Product Code | MRZ |
| Date Received | 2019-01-08 |
| Model Number | 1638502 |
| Catalog Number | 163850455 |
| Lot Number | 905025H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 | 2019-01-08 |