MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-24 for F8 DIALYZER FINISHED ASSY (CASE) 0500164A manufactured by Ogden Manufacturing Plant.
[146061446]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.?
Patient Sequence No: 1, Text Type: N, H10
[146061447]
A user facility reported that a dialyzer blood leak occurred immediately after the initiation of the patient? S hemodialysis (hd) treatment. There were no alarms from the fresenius 2008k hemodialysis machine used for treatment, as this was an external blood leak that was visually observed leaking from the dialyzer header cap. The patient? S estimated blood loss (ebl) was approximately 3ml. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient was restarted on a new machine and treatment completed successfully with a new dialyzer. The complaint device was reportedly discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2019-00166 |
| MDR Report Key | 8639952 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-24 |
| Date of Report | 2019-07-09 |
| Date of Event | 2019-05-10 |
| Date Mfgr Received | 2019-07-05 |
| Device Manufacturer Date | 2017-02-25 |
| Date Added to Maude | 2019-05-24 |
| 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 | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | OGDEN MANUFACTURING PLANT |
| Manufacturer Street | DIRECTOR, SITE QUALITY 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 | F8 DIALYZER FINISHED ASSY (CASE) |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2019-05-24 |
| Catalog Number | 0500164A |
| Lot Number | 17BU04020 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-05-24 |