MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-14 for BIPRO SYSTEMS SDS CB200 manufactured by Medical Solution.
[77647202]
Hemodialysis pts c/o nausea, vomit, hypotension in between change over of 1st and 2nd shift 10:00 am - 12:00pm. Staff identified bicarb tank. Malfunction in which bicarb in day tank was diluted, bicarb conductivity out of range, indicating dilution.
Patient Sequence No: 1, Text Type: D, B5
[77647203]
Hemodialysis pts c/o nausea, vomit, hypotension in between change over of 1st and 2nd shift 10:00 am - 12:00pm. Staff identified bicarb tank. Malfunction in which bicarb in day tank was diluted, bicarb conductivity out of range, indicating dilution.
Patient Sequence No: 2, Text Type: D, B5
[77647204]
Hemodialysis pts c/o nausea, vomit, hypotension in between change over of 1st and 2nd shift 10:00 am - 12:00pm. Staff identified bicarb tank. Malfunction in which bicarb in day tank was diluted, bicarb conductivity out of range, indicating dilution.
Patient Sequence No: 3, Text Type: D, B5
[77647205]
Hemodialysis pts c/o nausea, vomit, hypotension in between change over of 1st and 2nd shift 10:00 am - 12:00pm. Staff identified bicarb tank. Malfunction in which bicarb in day tank was diluted, bicarb conductivity out of range, indicating dilution.
Patient Sequence No: 4, Text Type: D, B5
| Report Number | MW5070418 |
| MDR Report Key | 6643186 |
| Date Received | 2017-06-14 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-06-07 |
| Date Added to Maude | 2017-06-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | BIPRO SYSTEMS SDS CB200 |
| Generic Name | MIXING AND DISTRIBUTION SYSTEM OF BICARBONATE FOR DIALYSIS |
| Product Code | FIN |
| Date Received | 2017-06-14 |
| Model Number | SDS CB200 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL SOLUTION |
| Manufacturer Address | 5646 MERRIAM DRIVE MERRIAM KS 66203 US 66203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-14 | |
| 2 | 0 | 2017-06-14 | |
| 3 | 0 | 2017-06-14 | |
| 4 | 0 | 2017-06-14 |