MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-06 for DAYSPRING manufactured by Dayspring Medical, Inc..
[15164]
Facility alleges salmie bag went dry even though occluding clamp was applied to salmie y connector. Rn reports machine alarmed and salmie bag noted to be dry. Infused salmie reentered into pt goal weight; weight 7 kg over target post dialysis. No pt complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00217 |
| MDR Report Key | 22205 |
| Date Received | 1995-04-06 |
| Date of Report | 1995-03-10 |
| Date of Event | 1995-02-15 |
| Date Facility Aware | 1995-03-03 |
| Report Date | 1995-03-10 |
| Date Reported to Mfgr | 1995-03-10 |
| Date Added to Maude | 1995-06-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAYSPRING |
| Generic Name | OCCLUDING CLAMP |
| Product Code | FIG |
| Date Received | 1995-04-06 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22308 |
| Manufacturer | DAYSPRING MEDICAL, INC. |
| Manufacturer Address | 1936 BEACON CT BOULDER CO 80302 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-04-06 |