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 2017-11-24 for OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 0500318E manufactured by Ogden Manufacturing Plant.
[93574687]
A follow up will be submitted following evaluation.
Patient Sequence No: 1, Text Type: N, H10
[93574688]
A hemodialysis clinic reported a blood leak at the beginning of the patient's treatment. The blood leak alarm went off and blood was visible in the drain line. Patient was moved to another set-up in order to complete treatment. During follow up the clinic reported the blood leak was internal only. Right at the start of patient treatment (when all the blood first went through the dialyzer), the machine alarmed blood leak. The leak was visually observed and blood test strips were also used which tested positive thus confirmed the presence of blood. The leak was observed at the arterial header end of the dialyzer, however, there was no observed defect or crack. The patient's blood was not returned, the estimated blood loss was stated 150cc. Treatment was stopped and the patient was able to complete treatment on a different machine with a new set up of supplies. No patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient was given prophylactic medication only and did not have any infection. Patient information was not disclosed. The dialyzer was not returned for evaluation at this time but may be available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00372 |
| MDR Report Key | 7057936 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-24 |
| Date of Report | 2018-01-22 |
| Date of Event | 2017-10-31 |
| Date Mfgr Received | 2018-01-04 |
| Device Manufacturer Date | 2017-07-27 |
| Date Added to Maude | 2017-11-24 |
| 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 | 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 | 2017-11-24 |
| Returned To Mfg | 2017-11-15 |
| Catalog Number | 0500318E |
| Lot Number | 17JU01018 |
| 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 | 2017-11-24 |