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 2017-11-17 for OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 0500318E manufactured by Ogden Manufacturing Plant.
[93210618]
The sample is not available for evaluation as it was discarded at the facility. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample. During the lot history review it was noted there are no other reported complaints against the lot. The production record was reviewed and there was one approved temporary dn noted on the lot. It is unrelated to the reported complaint event. There was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint. This includes non-conformances, rework, labeling, process controls and any other occurrence in production. The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.
Patient Sequence No: 1, Text Type: N, H10
[93210619]
Biomed from a user facility reported of a major blood leak across the dialyzer. During follow up the nurse team lead reported the patient was early in treatment and saline was just finished when the nurse at the machine noticed a blood leak from the top of the dialyzer (internal) the leak was apparent in the dialysate from the top end. There may have been an end cap issue as the leak originated near there. They did not use the blood test strips as the blood was readily visible. The machine did alarm as expected. The patient lost approximately 100 to 150 ml of blood before treatment was stopped. The patient was moved to another machine without incident. No serious adverse event was reported. The dialyzer is believed to have been discarded
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00365 |
| MDR Report Key | 7041403 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-10-21 |
| Date Mfgr Received | 2017-10-21 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2017-11-17 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2017-11-17 |
| Catalog Number | 0500318E |
| Lot Number | 17LU01001 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-11-17 |