MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for PREMIER PRO 8801 manufactured by S2s Global.
[100769082]
Patient Sequence No: 1, Text Type: N, H10
[100769083]
Pressure bag would not hold pressure despite appropriate use to pump up pressure to 300 mg hg and secure stopcock. Nurse had to reinfuse pressure into the bag multiple times. This pressure bag was being used on the radial artery line. The physician was not able to save the arterial line and it had to be discontinued and restarted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7291680 |
| MDR Report Key | 7291680 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-30 |
| Date of Event | 2017-11-20 |
| Report Date | 2018-01-29 |
| Date Reported to FDA | 2018-01-29 |
| Date Reported to Mfgr | 2018-01-29 |
| Date Added to Maude | 2018-02-23 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | PREMIER PRO |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2018-02-23 |
| Catalog Number | 8801 |
| ID Number | PREMIERPRO INFUSER WITH STOPC |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S2S GLOBAL |
| Manufacturer Address | 600 JEFFERSON PLAZA, SUITE 202 ROCKVILLE MD 20852 US 20852 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2018-02-23 |