MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-03 for NXSTAGE SYSTEM ONE SAK-403 manufactured by Nxstage Medical, Inc..
[144122579]
A review of the device history record (dhr) for the involved dialysate sack lot was conducted which confirmed the product met all quality criteria and manufacturing specifications prior to release. There is no evidence to suggest that a product malfunction occurred. The user guide provides instruction to maintain aseptic technique and warnings to follow instructions provided to prevent the risk of exposure to infectious diseases. Biocompatibility of the device has been established. Nxstage medical considers this report closed. No additional information will be provided.
Patient Sequence No: 1, Text Type: N, H10
[144122580]
A report was received on (b)(6) 2019 from the home therapy nurse (htn) of a (b)(6) male with multiple comorbidities including end-stage renal disease (esrd) and elevated liver function tests (lft), who experienced headache, fever (104. 5 f), tachycardia (117 bpm), numbness/tingling in his fingers, lower back pain, chills, hypotension (98/58), and increased lethargy approximately 50 minutes after initiating his first in-center hemodialysis treatment with the dialysate sack on (b)(6) 2019. Therapy was terminated, intravenous (iv) vancomycin (1. 5g) & ceftazidime (1. 5g) were administered, and the patient become unresponsive. Nasal oxygen (o2) was applied, and the patient was transported via ambulance and admitted to the intensive care unit (icu). Additional information received on (b)(6) 2019 from the htn revealed that evaluation in hospital included blood and stool cultures with no organism identified. Viral syndrome was suspected, and the iv antibiotics were ceased. Further blood tests, electrocardiogram (ekg) and chest x-ray (cxr) revealed no causative factors. The patient received a diagnosis of sepsis with acute organ dysfunction and was discharged in stable condition on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003464075-2019-00014 |
| MDR Report Key | 8579662 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-04-17 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2019-05-03 |
| 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 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NXSTAGE SYSTEM ONE |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM |
| Product Code | FKR |
| Date Received | 2019-05-03 |
| Model Number | SAK-403 |
| Catalog Number | SAK-403 |
| Lot Number | 90179285 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Manufacturer Address | 350 MERRIMACK STREET LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-03 |