MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-15 for ETHOX 950089904 manufactured by Ethox.
[77933341]
The customer did not return the affected device. Fifteen 3000 ml infusion bags were removed from inventory and pressurized into the red zone on the stick manometer. None of the bags failed. The investigator has processed several complaints were the mesh seam failed and the iv bag fell out of the infuser bag he has never processed a complaint where that pressure bag allegedly exploded. Two of the fully pressurized bags never processed a complaint where the pressure bag allegedly exploded. Two of the fully pressurized bags mentioned above were punctured with the tip of a knife to see if these was a violent reaction when punctured. Both bags quietly and non-violently vented the pressure. The punctures did not increase in size. The air just vented out in a very uneventful manner. The stick manometer on the pressure infusion bag not only indicates the pressure in the bag but it also acts as a pressure relief valve should the user attempt to over-inflate the bag using the hand pump.
Patient Sequence No: 1, Text Type: N, H10
[77933342]
The customer alleges "nurse had iv bag inflated inside the infu-bag. She walked past it while it was on the iv pole, it exploded apart and sent pressure to her ear. " no other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246980-2017-00020 |
| MDR Report Key | 6644138 |
| Date Received | 2017-06-15 |
| Date of Report | 2017-06-13 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2017-05-17 |
| Date Added to Maude | 2017-06-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TRISH FOWLER |
| Manufacturer Street | 2121 WILSHIRE STE 201 |
| Manufacturer City | SANTA MONICA CA 90403 |
| Manufacturer Country | US |
| Manufacturer Postal | 90403 |
| Manufacturer Phone | 3105767267 |
| Manufacturer G1 | ETHOX |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ETHOX |
| Generic Name | PRESSURE INFUSER BAG |
| Product Code | KZD |
| Date Received | 2017-06-15 |
| Returned To Mfg | 2017-07-21 |
| Model Number | 950089904 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHOX |
| Manufacturer Address | 2710 NORTHRIDGE DR. SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-15 |