MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-22 for MAHURKAR 8830415003 manufactured by Kendall/tyco Healthcare Group.
[1644452]
The patient had a new apheresis catheter placed in interventional radiology. She returned to her room. The apheresis was set up and initiated. The patient became unresponsive within 18 minutes and presented with symptoms of a stroke. A head ct scan showed an air embolism. The patient had a patent foramen ovale (pfo). The exact cause of the embolism is unknown and expected to be human error. Upon review of the case, we did note that the catheter used did not have a connection that would allow for the standard pheresis tubing or needless adaptor to screw completely onto the hub. There is a 1/4 turn on the connection, not a full turn seen with most other catheter connections. The exposed grooves could potentially act as a source for infection. Simulation of the connection with the pressure of apheresis did demonstrate a tight seal. However, the connection can come undone easily if not tight enough. It can also be difficult to remove if secured too tightly. In addition, the clamps used on the catheter have been reported by the rn staff to pop open easily. It is not always easy to see that they are open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651892 |
| MDR Report Key | 1651892 |
| Date Received | 2010-03-22 |
| Date of Report | 2010-03-22 |
| Date of Event | 2010-01-26 |
| Report Date | 2010-03-22 |
| Date Reported to FDA | 2010-03-22 |
| Date Added to Maude | 2010-04-06 |
| 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 | MAHURKAR |
| Generic Name | CATHETER DUAL LUMEN,CURVED EXTENSIONS,LASER-CUT SIDE SLOTS |
| Product Code | FJT |
| Date Received | 2010-03-22 |
| Model Number | 8830415003 |
| Catalog Number | 8830415003 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KENDALL/TYCO HEALTHCARE GROUP |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02084 US 02084 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2010-03-22 |