MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-07 for WING EATER SAFETY AV FISTULA NEEDLE SET 820-5002-33 manufactured by Jms Singapore Pte Ltd..
[94494940]
Three and three quarters into a scheduled 4 hour hemodialysis treatment, machine was alarming and patient was found vomiting and unconscious. B/p 57/37; pulse 65. When staff attempted to administer normal saline, it was noted that both arterial and venous needles were dislodged. Ebl on floor 200 ml. Patient was re-cannulated with a new fistula needle and a total of 400 ml normal saline was administered; pressure was held to the previous arterial/ venous cannulation sites. Oxygen applied at 3 liters via nasal cannula. Ems was called and patient was transported to the hospital, where she later died. Vs upon discharge from clinic: bp 140/66; pulse 135; total uf removed = 2340 ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7104846 |
| MDR Report Key | 7104846 |
| Date Received | 2017-12-07 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-11-24 |
| Date Facility Aware | 2017-11-24 |
| Report Date | 2017-12-05 |
| Date Reported to FDA | 2017-12-06 |
| Date Reported to Mfgr | 2017-12-06 |
| Date Added to Maude | 2017-12-11 |
| 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 | 3 |
| 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 | WING EATER SAFETY AV FISTULA NEEDLE SET |
| Generic Name | FISTULA NEEDLE |
| Product Code | FIE |
| Date Received | 2017-12-07 |
| Catalog Number | 820-5002-33 |
| Lot Number | 170802381 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JMS SINGAPORE PTE LTD. |
| Manufacturer Address | 440 ANG MO KIO INDUSTRIAL PARK 1 SIINGAPORE 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-12-07 |