MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-19 for NXSTAGE MEDICAL NSO CYCLER manufactured by Nxstage Medical Inc..
[88246155]
On (b)(6) 2017, (b)(6) rn, home hemodialysis nurse went to pt's home to help with cannulation. Upon cannulating, the nurse realized the blue clamp needle was in the arterial limb of the graft and the red clamp needle was in the venous limb of the graft. The pt refused re-cannulation. The nurse attached the red pt line to the blue needle (arterial side of graft), and the blue pt line to the red needle (venous side of graft). (b)(6) rn, home hemodialysis nurse stated she instructed pt on take-off procedure, labeled the needles for easy identification on take off. Pt verbalized understanding of which line she will utilize to return her blood. At the end of the hemodialysis treatment, the pt was found unresponsive by her mother, who has her care partner. The pt's mother reports that there was a large amount of blood on the floor. The pt's mother immediately shut off the cycler and called 911. Police and ems arrived at the home and transported the pt to (b)(6) hospital via ambulance. Dr. (b)(6) notified (b)(6) rn, home hemodialysis nurse at approx 3:15pm that the pt had expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6914000 |
| MDR Report Key | 6914000 |
| Date Received | 2017-09-19 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-07-26 |
| Date Facility Aware | 2017-07-26 |
| Report Date | 2017-08-25 |
| Date Reported to FDA | 2017-08-25 |
| Date Reported to Mfgr | 2017-08-25 |
| Date Added to Maude | 2017-10-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 0 |
| Brand Name | NXSTAGE MEDICAL NSO CYCLER |
| Generic Name | CYCLER |
| Product Code | KOC |
| Date Received | 2017-09-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL INC. |
| Manufacturer Address | 350 MERRIMACK STREET LAWRENCE MA 01843 US 01843 |
| Brand Name | CARTRIDGE 172C |
| Generic Name | CARTRIDGE |
| Product Code | KDI |
| Date Received | 2017-09-19 |
| Lot Number | 70277008 |
| Operator | NO INFORMATION |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL INC. |
| Manufacturer Address | 350 MERRIMACK STREET LAWRENCE MA 01843 US 01843 |
| Brand Name | MEDISYSTEMS TWIN PACK HEMODIALYSIS FISTULA NEEDLE SET 16G |
| Generic Name | NEEDLES |
| Product Code | FIE |
| Date Received | 2017-09-19 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| 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. Death | 2017-09-19 |