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 2017-11-28 for OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 0500318E manufactured by Ogden Manufacturing Plant.
[93577690]
There was no sample provided for evaluation. A definitive conclusion regarding the incident cannot be reached without examination of the complaint sample. During the lot history review it was noted there are three complaints from different customers reported against the lot. One of the complaints is the current complaint. The other two complaints are both unconfirmed with no samples returned. One addresses an internal blood leak and the other addresses a foreign matter found in a dialyzer. The production record was reviewed and there were two approved temporary dn? S noted on the lot. They are 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
[93577691]
A user facility reported of a dialyzer leak at the beginning of the patient's treatment. A blood leak test was administered and patient experienced minimal blood loss. During follow up the clinic reported there was no adverse event for the patient. The blood loss was lss than one circuit approximately 100 ml. The dialyzer was discarded. The machine alarmed right away and treatment was stopped, the patient completed treatment on another machine. Patient identity and demographics were not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00377 |
| MDR Report Key | 7065911 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-28 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2017-11-02 |
| Device Manufacturer Date | 2017-08-25 |
| Date Added to Maude | 2017-11-28 |
| 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 | 2017-11-28 |
| Catalog Number | 0500318E |
| Lot Number | 17KU03015 |
| 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 | 2017-11-28 |