MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-02-18 for F3 DIALYZER FINISHED ASSY 0500165A manufactured by Ogden Manufacturing.
[17890531]
A report has been received regarding an incident that occurred with an infant. The initial report was vague, however, the facility has reported a possible dialyzer reaction with a baby. In speaking with this facility, it was learned this pt had been receiving dialysis with use of this dialyzer when the md had noticed a shift on the wbc/differential and related the event to a dialyzer membrane reaction. It was reported this incident occurred from (b)(6) 2010 to (b)(6) 2011. No coughing or respiratory involvement, however, 80% monos were noted. Currently, this facility now triple rinses the dialyzer and add 200 units of heparin in the saline. In speaking with this unit again it was confirmed that this pt remains on this dialyzer and that these symptoms have resolved. Additionally, it was learned that this pt is described as having multiple medical conditions and remains inpatient. There is no sample and the lot is unk. No further info was able to be provided. It was reported that the symptoms have resolved. Of note: the facility reported this event occurred from (b)(6) 2010 to (b)(6) 2011. No further info available.
Patient Sequence No: 1, Text Type: D, B5
[17919667]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713747-2011-00005 |
| MDR Report Key | 2000895 |
| Report Source | 05,06,07 |
| Date Received | 2011-02-18 |
| Date of Report | 2011-02-18 |
| Date of Event | 2010-12-09 |
| Date Facility Aware | 2010-12-09 |
| Report Date | 2011-02-18 |
| Date Reported to Mfgr | 2011-01-20 |
| Date Mfgr Received | 2011-01-21 |
| Date Added to Maude | 2011-03-02 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MARGARET CHARETTE, RN |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F3 DIALYZER FINISHED ASSY |
| Generic Name | DIALYZER |
| Product Code | MSE |
| Date Received | 2011-02-18 |
| Model Number | NA |
| Catalog Number | 0500165A |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING |
| Manufacturer Address | OGDEN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-18 |