MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM manufactured by Nxstage Medical, Inc.
[185707601]
A nxstage circuit failure while continuous renal replacement therapy (crrt) was in process. Alarm stated: "alarm #37 - check for high balance chamber pressure". Rn called nxstage for phone assistance. Nxstage states it might be a microfilter issue. Circuit changed out with another circuit that has a different lot number. No harm came to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902902 |
| MDR Report Key | 9902902 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-03 |
| Report Date | 2020-03-16 |
| Date Reported to FDA | 2020-03-16 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
| Product Code | KDI |
| Date Received | 2020-03-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC |
| Manufacturer Address | 350 MERRIMACK ST LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |