MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-21 for PRESSURE INFUSER PRESS1000S manufactured by Medline Industries, Inc..
[67853282]
Patient Sequence No: 1, Text Type: N, H10
[67853283]
The patient was the in endovascular suites for treatment of a stroke. The pressure bag appeared to be fully inflated. The bag had approximately 200cc of heparinized saline and arterial blood from a catheter in the brain back flowed up into the chamber of the infusion tubing. Heparinized saline via the pressure infused is used to prevent clots forming during endovascular procedures. Manufacturer response for pressure bag/pressure infuser, 1000 ml pressor infuser (per site reporter).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6345758 |
| MDR Report Key | 6345758 |
| Date Received | 2017-02-21 |
| Date of Report | 2017-01-23 |
| Date of Event | 2016-11-14 |
| Report Date | 2016-11-22 |
| Date Reported to FDA | 2016-11-22 |
| Date Reported to Mfgr | 2016-11-22 |
| Date Added to Maude | 2017-02-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| 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 | PRESSURE INFUSER |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2017-02-21 |
| Catalog Number | PRESS1000S |
| Lot Number | 0761512000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-21 |