MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-05 for * manufactured by Hemametrics Inc..
[20021938]
The crit-line adapter became loose during hemodialysis treatment after the venous pressure increased. The adapter had been tightened prior to use. ====================== manufacturer response for crit-line adapter, (brand not provided)======================no response yet
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1044685 |
| MDR Report Key | 1044685 |
| Date Received | 2008-05-05 |
| Date of Report | 2008-05-02 |
| Date of Event | 2008-05-01 |
| Report Date | 2008-05-02 |
| Date Reported to FDA | 2008-05-05 |
| Date Added to Maude | 2008-05-15 |
| 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 | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | ADAPTER, HEMATOCRIT MONITOR |
| Product Code | JPI |
| Date Received | 2008-05-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 080203 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1012984 |
| Manufacturer | HEMAMETRICS INC. |
| Manufacturer Address | 695 NORTH 900 WEST KAYSVILLE UT 840374118 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-05 |