MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-12 for ALARIS PUMP 72213N 172021-08-132 manufactured by Carefusion 303 Inc.
[136595350]
Patient had a secondary medication attached to primary tubing and a pump. The patient did not receive the medication and it is either an issue with the medication tubing or the infusion pump. The medication in the secondary bag filled up with more fluid so unsure what dose of medication the patient received. Alaris pump from cardinal health, model # 8015, lot # 2013-8, serial # (b)(4), catalog # 10019205.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083961 |
| MDR Report Key | 8336141 |
| Date Received | 2019-02-12 |
| Date of Report | 2019-02-10 |
| Date of Event | 2019-02-08 |
| Date Added to Maude | 2019-02-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | ALARIS PUMP |
| Generic Name | PUMP INFUSION |
| Product Code | FRN |
| Date Received | 2019-02-12 |
| Model Number | 72213N |
| Catalog Number | 172021-08-132 |
| Lot Number | 1018085692 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 303 INC |
| Brand Name | IV TUBING |
| Generic Name | IV TUBING |
| Product Code | OJA |
| Date Received | 2019-02-12 |
| Model Number | 8015 |
| Catalog Number | 10019205 |
| Lot Number | 2013-8 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200 LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-12 |