MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-18 for MAHURKAR DUAL LUMEN CATHETER 8815-668007-1 * manufactured by Tyco Healthcare Group, Lp.
[18826964]
In 2005 left femoral mahurkar (quinton) catheter was inserted. The next day at approximately 7:05 am pt was found unresponsive, lying in a large amount of blood; the left femoral venous catheter was found uncapped and unclamped. Pt was coded and resuscitated, however, died later that morning. Initial investigation did not identify a potential problem with the device. However, upon closer analysis in 3/05, of a duplicate device, the adequacy of the clamp and cap mechanism were questioned as being easily loosened or removable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 582576 |
| MDR Report Key | 582576 |
| Date Received | 2005-03-18 |
| Date of Report | 2005-03-09 |
| Date of Event | 2005-01-19 |
| Date Facility Aware | 2005-03-02 |
| Report Date | 2005-03-08 |
| Date Reported to FDA | 2005-03-08 |
| Date Reported to Mfgr | 2005-03-08 |
| Date Added to Maude | 2005-03-21 |
| 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 | 3 |
| 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 | MAHURKAR DUAL LUMEN CATHETER |
| Generic Name | HEMODIALYSIS CATHETER, APHERESIS AND INFUSION |
| Product Code | LFK |
| Date Received | 2005-03-18 |
| Model Number | 8815-668007-1 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Device Expiration Date | 2007-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 572404 |
| Manufacturer | TYCO HEALTHCARE GROUP, LP |
| Manufacturer Address | * MANSFIELD MA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-03-18 |