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 2017-11-03 for OPTIFLUX F160NRE DIALYZER 0500316E manufactured by Ogden Manufacturing Plant.
[92068192]
The dialyzer has not been returned for evaluation to date. During the lot history review it was noted that there are no other reported complaints against the lot. The production record was reviewed and 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
[92068193]
Clinic nurse reported a dialyzer blood leak one hour into patient's treatment. During follow up a clinic nurse reported that the patient did not require any medical intervention and was moved to another machine to complete dialysis. The machine alarmed and blood was visible in the dialysate. No test strip was used. The blood loss was approximately 200 cc or one complete circuit. The dialyzer was not made available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00356 |
| MDR Report Key | 7001137 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-03 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-10-10 |
| Date Mfgr Received | 2017-10-10 |
| Device Manufacturer Date | 2017-05-12 |
| Date Added to Maude | 2017-11-03 |
| 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 F160NRE DIALYZER |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2017-11-03 |
| Catalog Number | 0500316E |
| Lot Number | 17EU06014 |
| 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 | 2017-11-03 |