MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-16 for JMS WINGEATER FISTULA NEEDLE manufactured by Jms Singapore Pte Ltd..
[92477556]
As ccrt was approaching pt to perform 30 min vital sign check 2 hrs into a scheduled 4 hrs incenter hemodialysis treatment, the fresenius 2008k machine started alarming. Pt was found unresponsive to verbal and painful, stimuli and blood was noted on floor under pt's chair, ebl > 300 ml. Pt was placed in trendelenburg position. Venous needle was noted to be dislodged. B/p was 83/40, pulse 67. Treatment was paused. Pressure applied to venous cannulation site. Arterial needle was recure and intact. Arterial blood was returned and 500 ml normal saline was infused via the arterial line; oxygen was applied at 10 lpm via face mask. Ems was called. An add'l 500ml normal saline was given. Respirations were even and unlabored; pt remained unresponsive to verbal and painful stimuli. Vital signs prior to transfer 135/72, pulse 90. Pt transported to hospital via ems and admitted to ccu. Pt discharged from hospital to home (b)(6) 2017. Ref mfr 3002807350-2017-00007.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7037304 |
| MDR Report Key | 7037304 |
| Date Received | 2017-11-16 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-10-04 |
| Date Facility Aware | 2017-10-04 |
| Report Date | 2017-10-13 |
| Date Reported to Mfgr | 2017-10-16 |
| Date Added to Maude | 2017-11-16 |
| 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 | JMS WINGEATER FISTULA NEEDLE |
| Generic Name | FISTULA NEEDLE 15 GAUGE 1 INCH |
| Product Code | FIE |
| Date Received | 2017-11-16 |
| Lot Number | 170531371 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JMS SINGAPORE PTE LTD. |
| Manufacturer Address | SINGAPORE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-11-16 |