MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-08-03 for * NA manufactured by *.
[16375006]
It has been clarified by the reporter of the event that 17 of the 41 pts dialyzed at this unit in 2007 experienced a drop in hemoglobin, possibly related to the use of this product. This particular pt reportedly presented with behavioral changes and was admitted to the hospital and was diagnosed with a cva. This pt has recovered and is doing well receiving hemodialysis.
Patient Sequence No: 1, Text Type: D, B5
[16648947]
It is the opinion that the possible incorrect use of the product may have caused or contributed to these events. Also of note is that the product had exceeded the expiration date when used by facility. Device history record review: it has been verified that puristeril lot# 100611 had met all specifications prior to its release.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221361-2007-00056 |
| MDR Report Key | 893593 |
| Report Source | 05,06 |
| Date Received | 2007-08-03 |
| Date of Report | 2007-08-03 |
| Date Mfgr Received | 2007-07-09 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2007-08-14 |
| 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 | 0 |
| Manufacturer Contact | MARGARET CHARETTE, RN |
| Manufacturer Street | 920 WINTER ST |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999070 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | LIF |
| Date Received | 2007-08-03 |
| Model Number | * |
| Catalog Number | NA |
| Lot Number | * |
| ID Number | * |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 870365 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2007-08-03 |