MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-10 for REVEACLEAR DIALYIZER REVEALCEAR manufactured by Gambro.
[4035623]
Visible blood leak noted in the dialyzer at 7:55 am while pt was undergoing hd treatment. Hd machine alarmed (blood leak detected). Placed machine in bypass mode and blood pump stopped. The entire system was discarded without returning the blood. Approximate blood loss was 200 ml per extra corporeal circuit volume. New system was set up and resumed treatment without any problem. Vital signs stable and monitored. Alarm: blood in dialysate during hd treatment at 0755, (b)(6) 2014. Dialyzer: revaclear dialyzer by gambro dialysis treatment was stopped immediately and blood was not returned (200 ml blood loss). Gambro quality management was notified (b)(4). Gambro will send a packaging kit so that (b)(6) can send dialyzer to gambro tomorrow, (b)(6) 2014 for analysis and quality check. Pt was hooked up to x36 phoenix gambro machine ph 25643 -machine was pulled out off the dialysis floor immediately after alarm went off. New dialyzer and new machine were used. Gambro rep will check dialysis machine tomorrow, (b)(4) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033856 |
| MDR Report Key | 3576439 |
| Date Received | 2014-01-10 |
| Date of Report | 2014-01-09 |
| Date of Event | 2014-01-09 |
| Date Added to Maude | 2014-01-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVEACLEAR DIALYIZER |
| Generic Name | DIALYZER |
| Product Code | FII |
| Date Received | 2014-01-10 |
| Model Number | REVEALCEAR |
| Lot Number | C413125301 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | US |
| Brand Name | X36 PHOENIX GAMBRO MACHINE |
| Generic Name | DIALYSIS MACHINE |
| Product Code | FJI |
| Date Received | 2014-01-10 |
| Model Number | 25643 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-10 |