MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-28 for MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) D9-2005MG MEDISYSTEMS MASTERGUARD? manufactured by Medisystems Corporation (a Nxstage Company).
[87724543]
Treatments in a dialysis center are performed by trained and qualified personnel who provide continuous monitoring and check for leaks during treatment in order to respond to alarms and potentially harmful conditions promptly. The device has not been received for investigation. A review of the database revealed no other events have been received for the reported lot number. (b)(4). Nxstage medical considers this report closed. No additional information will be provided.
Patient Sequence No: 1, Text Type: N, H10
[87724544]
A report was received on (b)(6) 2017 regarding a (b)(6)-old male patient treating in a dialysis center on (b)(6) 2017 who was hypotensive and unresponsive to verbal stimuli after experiencing approximately 200 ml blood loss during treatment. Blood was found to be coming from a crack in the connector at the distal end of the tubing segment of the arteriovenous fistula (avf) needle. The patient? S symptoms improved after administration of nasal oxygen and a 500 ml intravenous saline bolus. Treatment was continued with an alternate avf needle. On completion of the treatment, the physician sent the patient to the emergency room where the patient was admitted on (b)(6) 2017 and received two units of packed red blood cells (rbc's). The patient was discharged on (b)(6) 2017. The patient continued his next treatment at the dialysis center when he was released from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919260-2017-00003 |
| MDR Report Key | 6902004 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-08-31 |
| Date Mfgr Received | 2017-09-01 |
| Device Manufacturer Date | 2017-04-12 |
| Date Added to Maude | 2017-09-28 |
| 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 | 9786874700 |
| 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 | MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) |
| Generic Name | NEEDLE, FISTULA |
| Product Code | FIE |
| Date Received | 2017-09-28 |
| Model Number | D9-2005MG |
| Catalog Number | MEDISYSTEMS MASTERGUARD? |
| Lot Number | 170420F3 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) |
| Manufacturer Address | 350 MERRIMACK STREET LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-09-28 |