MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-09-13 for LUNDIA ALPHA 700 N01849004 manufactured by Gambro Healthcare.
[27997]
During a dialysis treatment, there was an external blood leak. From the plastic knob above the label. The blood was running down the dialzyer. Blood loss was estimated at 10-15cc. There was no pt impact.
Patient Sequence No: 1, Text Type: D, B5
[7760761]
Investigation/determination of cause: samples received from same lot number were tested in simulated dialysis with bovine blood or a colored water solution in the the blood compartment of the dialyzer. This test was to detect any leaks in the sealing plug area. The tests are done according to the requirements in the ansi/aami standard for first use hemodialyzers using a pressure in the blood compartment which is 1. 5 times the stated maximum allowable pressure for the actual device. The result from the test indicated a small leak (few droplets) at the sealing plug on one dialyzer when the dialyzer was tested with the colored water solution. No leaks occurred during the test with bovine blood. Investigation of the leakage dialyzer confirmed a small damage on the surface of the sealing plug. A review and investigation of the process equipment used to mfr 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. Adjustments of the complete plugging station have earlier been rechecked on 8-9-96. Follow-up action: as part of a 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 on the plug in the plug station and reduce any possibilities for random damages to the plug. The mfr will continue to monitor and trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030992-1996-00002 |
| MDR Report Key | 40169 |
| Report Source | 06 |
| Date Received | 1996-09-13 |
| Date of Report | 1996-09-13 |
| Report Date | 1996-09-13 |
| Date Mfgr Received | 1996-08-13 |
| Date Added to Maude | 1996-10-02 |
| 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 |
| 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 | 1996-09-13 |
| Model Number | LUNDIA ALPHA 700 |
| Catalog Number | N01849004 |
| Lot Number | 6-0088-L01 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 41289 |
| Manufacturer | GAMBRO HEALTHCARE |
| Manufacturer Address | 1185 ST LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-09-13 |