MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-30 for BAXTER PERITONEAL DIALYSIS DIANEAL 5B9766 manufactured by Baxter Healthcare Corp..
[34074288]
During home visit patient was performing dianeal bag check prior to exchange, the bag was 2000ml 1. 5% low calcium, when it was noted to have a large amount of condensation inside the tubing. Frangibles still intact. Dianeal bag not used, 13 cases pulled from patient's home stock and returned to baxter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5313841 |
| MDR Report Key | 5313841 |
| Date Received | 2015-11-30 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-11-10 |
| Date Facility Aware | 2015-11-10 |
| Report Date | 2015-11-24 |
| Date Added to Maude | 2015-12-21 |
| 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 | 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 | BAXTER PERITONEAL DIALYSIS DIANEAL |
| Generic Name | PD FLUID ULTRABAG |
| Product Code | KPF |
| Date Received | 2015-11-30 |
| Returned To Mfg | 2015-11-11 |
| Catalog Number | 5B9766 |
| Lot Number | C992461 |
| Device Expiration Date | 2017-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 30 DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | 25212 W. IL RTE 120 ROUND LAKE IL 60073 US 60073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-30 |