MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-10 for OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 0500318E manufactured by Ogden Manufacturing Plant.
[92677765]
A follow up will be submitted following evaluation.
Patient Sequence No: 1, Text Type: N, H10
[92677766]
A hemodialysis nurse reported a dialyzer blood leak 27 minutes into the patient's treatment. The blood leak was visible in the dialysate and the leak appeared to be from the arterial end. They could not tell if strand broke or leak around cap. The patient's treatment was stopped with approximately 300 cc blood loss. The patient did not have any adverse event and did not need medical intervention. The patient chose not to complete treatment that day and left against medical advice. The patient's next treatment was normal. They were using blood test strips and they came back positive. The dialyzer may be available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00360 |
| MDR Report Key | 7023246 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-10 |
| Date of Report | 2018-02-22 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2018-02-21 |
| Device Manufacturer Date | 2017-08-13 |
| Date Added to Maude | 2017-11-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | OGDEN MANUFACTURING PLANT |
| Manufacturer Street | 475 WEST 13TH STREET |
| Manufacturer City | OGDEN UT 84404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2017-11-10 |
| Returned To Mfg | 2017-11-27 |
| Model Number | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. |
| Catalog Number | 0500318E |
| Lot Number | 17KU03007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING PLANT |
| Manufacturer Address | 475 WEST 13TH STREET OGDEN UT 84404 US 84404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-10 |