MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1996-09-26 for LUNDIA ALPHA 700 N084004 manufactured by Gambro Healthcare.
[30083]
During a dialysis treatment, there was an external blood leak from the sealing plug above the label. Blood loss was estimated at 15cc. There was no pt injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[7771058]
A review and investigation of the process equipment used to manufacture the plug as well as the plugging station in the dialyzer assembly line were done to find possible reasons for defects or small damages to the sealing plug which occasionally may cause leakage. The plugging station design was reviewed and a small change was done to the plug entrance channel to facilitate the movement of the plug and avoid random damages. The activities on the plugging station were done on 10-3-96. The adjustments of the complete plugging station have earlier been rechecked on 8-9-96. As part of continuing improvement program the moulding tool for the plug was polished to avoid any occurrence of surface roughness. This action implemented 9-2-96 will facilitate the movement of the plug in the plug station and reduce any possibilities for random damages to the plug. Customer contacted:n. Sales/ service ontacted by investigator:n. Training required:n.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030992-1996-00003 |
| MDR Report Key | 45870 |
| Report Source | 05,06,07 |
| Date Received | 1996-09-26 |
| Date of Report | 1996-09-26 |
| Date of Event | 1996-08-24 |
| Date Facility Aware | 1996-08-24 |
| Report Date | 1996-09-26 |
| Date Reported to Mfgr | 1996-08-26 |
| Date Mfgr Received | 1996-08-26 |
| Date Added to Maude | 1996-11-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUNDIA ALPHA 700 |
| Generic Name | PLATE DIALYZER |
| Product Code | FJG |
| Date Received | 1996-09-26 |
| Model Number | NA |
| Catalog Number | N084004 |
| Lot Number | 6-0900-L01 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 46726 |
| Manufacturer | GAMBRO HEALTHCARE |
| Manufacturer Address | 1185 OAK STREET LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-09-26 |