MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for FOLFUSOR 2C4063K manufactured by Baxter Healthcare Corporation.
[184933427]
The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184933428]
It was reported two (2) large volume folfusors underinfused. The reporter stated that at the end of the expected therapy time of 24 hours, a small amount (around 40-45 grams) of solution remained in each device. The devices had been filled with 230mls of unspecified solution. This issue was identified after use of on a patient. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[188642087]
Additional information was added: the device was manufactured from may 10, 2019 - may 14, 2019. Two (2) devices were received for evaluation. A visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition. A functional flow rate test was performed and found both devices to be within the product specification range. The reported condition was not verified. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2020-01724 |
| MDR Report Key | 9880397 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-05-10 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - IRVINE |
| Manufacturer Street | 17511 ARMSTRONG AVENUE BUILDING 3 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOLFUSOR |
| Generic Name | PUMP, INFUSION, ELASTOMERIC |
| Product Code | MEB |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-12 |
| Model Number | NA |
| Catalog Number | 2C4063K |
| Lot Number | 19E041 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |