MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-20 for NXSTAGE SYSTEM ONE CAR-172 manufactured by Nxstage Medical, Inc..
[188244242]
There was no indication of a device malfunction. All devices must meet quality requirements and manufacturing specifications prior to release. Bio-compatibility has been established. The instructions for use warns that the device must be used under the prescription of a physician. The user guide includes a decrease in platelet count as a potential risk associated with dialysis therapy and states monitoring of the patient should be performed regularly to ensure an appropriate response to therapy.
Patient Sequence No: 1, Text Type: N, H10
[188244283]
A report was received on 22 feb 2020 from a healthcare professional regarding an adult with end stage renal disease who experienced a platelet decrease after using the nxstage device, dates not provided. The patient's kidney transplant surgery was delayed due to the reported issue on an unspecified date, approximately two months earlier, prior to the date the report was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003464075-2020-00017 |
| MDR Report Key | 9861145 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-01 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-22 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Manufacturer Contact | MS. PAULA ROGALSKI |
| Manufacturer Street | NXSTAGE MEDICAL, INC 350 MERRIMACK STREET |
| Manufacturer City | LAWRENCE MA 01843 |
| Manufacturer Country | US |
| Manufacturer Postal | 01843 |
| Manufacturer Phone | 9784505276 |
| Manufacturer G1 | MEDIMEXICO S. DE R. L. DE C. V |
| Manufacturer Street | AV. VALLE IMPERIAL NO. 10523 PARQUE INDUSTRIAL VALLE SUR |
| Manufacturer City | TIJUANA 22180 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22180 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NXSTAGE SYSTEM ONE |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM |
| Product Code | KDI |
| Date Received | 2020-03-20 |
| Model Number | CAR-172 |
| Catalog Number | CAR-172 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Manufacturer Address | 350 MERRIMACK STREET LAWRENCE MA 01843 US 01843 |
| Brand Name | ACETAMINOPHEN 500MG |
| Product Code | --- |
| Date Received | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |