MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,05,06 report with the FDA on 2010-09-29 for F6 DIALYZER FINISHED ASSY (CASE) 0500145A manufactured by Ogden Manufacturing.
[1378826]
We have received a report indicating that a home hemodialysis patient had "blood leak" during treatment. It was verified that there was an internal blood leak that occurred after speaking with the patient's mother. At that time, no additional information was provided on the event. Additional information was received on september 02, 2010 from the clinic. The rn from (b)(6) hospital had reported that this patient was hospitalized on (b)(6)2010 and received blood on (b)(6). Reportedly, it was learned, that the reason for admission was an access site infection. The patient received intravenous treatment with antibiotics. Currently, this patient has been discharged as of the (b)(6). It is reported that the patient has recovered. Companion samples are available for evaluation. Of note: in speaking to the nurse, it was identified that it is normal for this patient to receive a transfusion usually occurring 1 to 2 times per year and the nurse had stated that "perhaps this transfusion was given due to the infection" and that "the body does not respond to epo as well". The nurse also reported that the patient has an extensive medical history and is severely disabled. The nurse was not able to confirm if the internal blood leak caused or contributed to this event.
Patient Sequence No: 1, Text Type: D, B5
[8788465]
(b)(6)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713747-2010-00035 |
| MDR Report Key | 1852437 |
| Report Source | 00,04,05,06 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-09-28 |
| Date of Event | 2010-08-10 |
| Report Date | 2010-09-28 |
| Date Reported to Mfgr | 2010-08-16 |
| Date Mfgr Received | 2010-09-02 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2010-10-07 |
| 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 | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F6 DIALYZER FINISHED ASSY (CASE) |
| Generic Name | DIALYZER |
| Product Code | MSE |
| Date Received | 2010-09-29 |
| Model Number | NA |
| Catalog Number | 0500145A |
| Lot Number | 10AU03015 |
| ID Number | NA |
| Device Expiration Date | 2013-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 7 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 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2010-09-29 |