MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-02 for CAREFUSION 10015862 manufactured by Carefusion.
[32979178]
Vincristine was being administered in the outpatient pediatric infusion center at a rate of 900ml/hr to infuse over 5 minutes via primary chemo tubing via an alaris pcu and large volume module. Treatment of acute leukemia (all) in remission. The patient stated that he felt something dripping. When investigating the tubing it was found to have a leak at the drip chamber above the pump. Due to the nature of the vesicant being administered, chemo precautions and spill management began including washing the patient's skin with soap and water for 10-15 minutes and removal and disposal of his sock as there were traces of the medication on it as well. No further medication or interventions made. Recurring event over time. One time use for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058355 |
| MDR Report Key | 5273167 |
| Date Received | 2015-12-02 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-11-25 |
| Date Added to Maude | 2015-12-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREFUSION |
| Generic Name | PRIMARY IV PUMP TUBING FOR CHEMO |
| Product Code | CAR |
| Date Received | 2015-12-02 |
| Catalog Number | 10015862 |
| Lot Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-02 |