MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-26 for F6 DIALYZER FINISHED ASSY 0500145A manufactured by Ogden Manufacturing.
[15540752]
A report has been rec'd indicating that during dialysis treatment, an internal blood leak was detected with the use of this dialyzer. Reportedly, this is an inpatient who was in the telemetry unit and the pt's condition was described as being weak due to cardiac issues unrelated to this event. The incident occurred approx ten to fifteen minutes into treatment with an estimated blood loss of 100-150 mls. An h & h was drawn and oxygen was administered following the event. The h & h were reported as being fine. The pt completed dialysis with the use of new product and a new machine and has since discharged from the hosp. The admission was unrelated as the pt was admitted prior to the event.
Patient Sequence No: 1, Text Type: D, B5
[15867280]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713747-2011-00016 |
| MDR Report Key | 2142122 |
| Report Source | 05,06 |
| Date Received | 2011-05-26 |
| Date of Report | 2011-05-26 |
| Date of Event | 2011-05-10 |
| Date Facility Aware | 2011-05-10 |
| Report Date | 2011-05-26 |
| Date Reported to Mfgr | 2011-05-10 |
| Date Mfgr Received | 2011-05-10 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2011-08-29 |
| 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 Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999070 |
| Single Use | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F6 DIALYZER FINISHED ASSY |
| Generic Name | DIALYZER |
| Product Code | MSE |
| Date Received | 2011-05-26 |
| Model Number | NA |
| Catalog Number | 0500145A |
| Lot Number | 10LU04011 |
| ID Number | NA |
| Device Expiration Date | 2013-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING |
| Manufacturer Address | OGDEN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-26 |