MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-22 for PRESS1000S manufactured by Medline Industries Inc..
[70871944]
It was reported the infuser was being used to assist in the administration of heparinized saline during a stroke procedure. In the middle of the procedure it was identified that the bag appeared inflated but had allowed back flow of arterial blood and fluid into the tubing. The infuser was checked regularly throughout the procedure, appeared to be fully inflated, and the pressure gauge indicated it was fully inflated. The physician stopped the procedure and a new pressure infuser, bag of heparinized/saline and new tubing were obtained and replaced in a sterile manner. This incident did not affect the outcome of the patient, and the procedure continued without further incident. A sample was not received and a root cause cannot be determined. A problem with the tubing or the bag of heparinized/saline cannot be ruled out as a contributing factor to the backflow of arterial blood. Due to the reported incident and in an abundance of caution this medwatch is being filed. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[70871945]
It was reported the pressure infuser allowed back flow of fluid into tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00016 |
| MDR Report Key | 6425425 |
| Date Received | 2017-03-22 |
| Date of Report | 2017-03-22 |
| Date of Event | 2016-11-12 |
| Date Mfgr Received | 2017-03-06 |
| Device Manufacturer Date | 2015-12-01 |
| Date Added to Maude | 2017-03-22 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8477703962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | PRESSURE INFUSER |
| Product Code | KZD |
| Date Received | 2017-03-22 |
| Catalog Number | PRESS1000S |
| Lot Number | 0761512000 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2017-03-22 |