MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-03 for WINGEATER JMS 15 GAUGE X 1 INCH BE WITH CLAMP FUSTULA N 820-5002-33 manufactured by Jms Singapore Pte Ltd.
[123422229]
At 12:35, approx 1 hour 30 mins into scheduled 3. 5 hour hemodialysis treatment, pt's b/p was 90 systolic and pt was difficult to arouse. Vs at 12:06: b/p: 118/62; pulse 87. Blood was noted under pt's chair. The blood pump was stopped and access was assessed. Arm was noted to have dropped into chair, causing tension on venous line. The venous fistula needle was noted to be dislodged. Pressure was held to venous site; blood was returned and normal saline was administered via the arterial fistula needle. Oxygen was applied via nasal cannula; 911 was called. Pt did not arouse with painful stimuli; pt appeared to have agonal breaths with no pulse. Cpr was initiated with one round administered before pt opened eyes and mumbled to staff. Palpable pulse and apical heart sounds auscultated. Approx 800 ml normal saline administered. Hemostasis achieved on venous cannulation site. Pt transported to er via ems. Admitted to hosp and transfused with 2 units packed red blood cells. Upon inspection of the venous avf needle, it was noted that the tape and gauze dressing were still intact on the fistula needle.
Patient Sequence No: 1, Text Type: D, B5
[123437100]
This is a f/u report to a previously submitted medwatch. Info was obtained as follows: pt was discharged from the hospital on (b)(6) 2018 and sustained a cardiopulmonary arrest in her home on (b)(6) 2018, resulting in her death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7955393 |
| MDR Report Key | 7955393 |
| Date Received | 2018-10-03 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-08 |
| Date Facility Aware | 2018-09-21 |
| Report Date | 2018-09-28 |
| Date Reported to FDA | 2018-10-04 |
| Date Reported to Mfgr | 2018-09-28 |
| Date Added to Maude | 2018-10-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | WINGEATER JMS 15 GAUGE X 1 INCH BE WITH CLAMP FUSTULA N |
| Generic Name | AV FISTULA NEEDLE |
| Product Code | FIE |
| Date Received | 2018-10-03 |
| Model Number | 820-5002-33 |
| Lot Number | 180116351 |
| 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 | SINGAPORE 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 160 | 1. Death; 2. Hospitalization; 3. Life Threatening | 2018-10-03 |