MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-10-20 for HUDSON CONCHAPAK SW 1650 ML W/COLUMN 385-60 manufactured by Telefelx Medical.
[19661325]
The event is reported as: infant patient was placed on comfort-flo set-up flow rate of 51pm with the heater column provided in package. Within a couple minutes, the system flooded the entire circuit with water. The column was changed out to a standard column and it also filled with water. The unit was trade out with no further issue. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[19752383]
Product has not yet been received by manufacturer, therefore, the investigation report is incomplete at this time. A follow-up report will be submitted when investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417411-2010-00045 |
| MDR Report Key | 1886312 |
| Report Source | 06,07 |
| Date Received | 2010-10-20 |
| Date of Report | 2010-09-30 |
| Date of Event | 2010-09-30 |
| Date Mfgr Received | 2010-09-30 |
| Date Added to Maude | 2011-02-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TAGGART, VP |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334916 |
| Manufacturer G1 | TELEFELX MEDICAL |
| Manufacturer Street | 900 WEST UNIVERSITY DR. |
| Manufacturer City | ARLINGTON HEIGHTS IL 60004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60004 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON CONCHAPAK SW 1650 ML W/COLUMN |
| Generic Name | CONCHAPAK |
| Product Code | BYF |
| Date Received | 2010-10-20 |
| Model Number | NA |
| Catalog Number | 385-60 |
| Lot Number | 02810A |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFELX MEDICAL |
| Manufacturer Address | ARLINGTON HEIGHTS IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-20 |