MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-03 for CGH LUNDIA ALPHA 600 (PL/CU/1.3/L) 0122606 manufactured by Gambro Healthcare.
[18447799]
Facility reported that 2 mins into treatment there was a blood leak. Ebl>100cc. A new dialyzer was used and treatment resumed without incident.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2243621-1996-00128 |
MDR Report Key | 33475 |
Date Received | 1996-05-03 |
Date of Report | 1996-05-02 |
Date of Event | 1996-04-23 |
Date Facility Aware | 1996-05-01 |
Report Date | 1996-05-02 |
Date Reported to FDA | 1996-05-03 |
Date Reported to Mfgr | 1996-05-03 |
Date Added to Maude | 1996-06-19 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CGH LUNDIA ALPHA 600 (PL/CU/1.3/L) |
Generic Name | DIALYZER |
Product Code | FJG |
Date Received | 1996-05-03 |
Catalog Number | 0122606 |
Lot Number | 5-0563-N |
Operator | OTHER |
Device Availability | N |
Device Age | NO INFO |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 34815 |
Manufacturer | GAMBRO HEALTHCARE |
Manufacturer Address | PO BOX 101460 ATLANTA GA 30392 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1996-05-03 |