MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-03 for WALKMED? 204821 IPR-150 manufactured by Walkmed Infusion Llc.
[88017021]
Patient Sequence No: 1, Text Type: N, H10
[88017022]
Patient did not actually receive medication due to adverse drug event from another medication. This patient's fluorouracil (5-fu) bag was made and stored for future use. Upon inspection in storage it was discovered that it had leaked. No patient harm. Patient came to clinic for 5-fu disconnect and ivf. When pump examined crystallization noted around pump and on pouch. The 5-fu was disconnected with 2 ml remaining. No patient harm. Pharmacist reported that patient's fluorouracil infusion bag was leaking and had to be replaced. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6910225 |
| MDR Report Key | 6910225 |
| Date Received | 2017-10-03 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-09-07 |
| Report Date | 2017-09-19 |
| Date Reported to FDA | 2017-09-19 |
| Date Reported to Mfgr | 2017-09-19 |
| Date Added to Maude | 2017-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | WALKMED? |
| Generic Name | BAG, RESERVOIR |
| Product Code | BTC |
| Date Received | 2017-10-03 |
| Returned To Mfg | 2017-09-19 |
| Model Number | 204821 |
| Catalog Number | IPR-150 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALKMED INFUSION LLC |
| Manufacturer Address | 14190 EAST JEWELL AVE UNIT 10 AURORA CO 80012 US 80012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-03 |