MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-20 for F3 DIALYZER FINISHED ASSY 0500165A manufactured by Ogden Manufacturing.
[19266227]
A hemodialysis user facility has reported the following incident: within 4 minutes of starting hemodialysis, the alarm indicated a minor blood leak which was confirmed both visually and with the use of a reagent test strip. The facility was contacted regarding this event and the following new info was learned. The amount of blood loss was estimated to be 48 ml's. The treatment was stopped and the pt was transfused with 250 ml's of blood. The reporter of the event stated that the pt was critically ill both prior to this event and after the transfusion and that the transfusion given, was for other than just the dialyzer leak. This pt was re-started on dialysis with use of a new treatment set, and remains in the same critical status in the pediatric icu unchanged since this event. This pt continues hemodialysis as ordered. There is no sample.
Patient Sequence No: 1, Text Type: D, B5
[19427962]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713747-2011-00011 |
| MDR Report Key | 2067964 |
| Report Source | 05,06 |
| Date Received | 2011-04-20 |
| Date of Report | 2011-04-20 |
| Date of Event | 2011-03-01 |
| Date Facility Aware | 2011-03-01 |
| Report Date | 2011-04-20 |
| Date Reported to Mfgr | 2011-03-22 |
| Date Mfgr Received | 2011-03-22 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2011-04-26 |
| 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 |
| Manufacturer Phone | 7816999070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F3 DIALYZER FINISHED ASSY |
| Generic Name | DIALYZER |
| Product Code | MSE |
| Date Received | 2011-04-20 |
| Model Number | NA |
| Catalog Number | 0500165A |
| Lot Number | 09PU04003 |
| ID Number | NA |
| Device Expiration Date | 2012-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 16 MO |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2011-04-20 |