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 1996-10-02 for LUNDIA ALPHA 700 N01849004 manufactured by Gambro Healthcare.
[31032]
During a dialysis treatment, there was an external blood leak at the sealing plug above the label. There was no pt injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[7772019]
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 blood compartment of dialyzer. This test was to detect any leaks in sealing plug area. Tests are done according to requirements ansi/aami standard for first use hemodialyzers using a pressure in blood compartment which is 1. 5 times stated maximum allowable pressure for actual device. Result from test indicated a small leak (few droplets) at sealing plug on one dialyzer when dialyzer was tested with colored water solution. No leaks occurred during test with bovine blood. Investigation of leaking dialyzer confirmed a small damage on surface of sealing plug. A review and investigation of process equipment used to manufacture plug as well as plugging station in dialyzer assembly line were done to find possible reasons for defects or small damages to sealing plug which occasionally may cause leakage. Plugging station design was reviewed and a small change was done to plug entrance channel to facilitate movement of plug and avoid random damages. Acivities on plugging station were done on 10/3/96. Adjustments of complete plugging station have earlier been rechecked on 8/9/96. Folow-up action: as part of a continuing improvement program, moulding tool for plug was polished to avoid any occurrence of surface roughness. This action implemented 9/2/96 will faiclitate movement of plug in plug station and reduce any possibilites for random damages to plug. Mfr will continue ot monitor and trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030992-1996-00004 |
| MDR Report Key | 47641 |
| Report Source | 05,06,07 |
| Date Received | 1996-10-02 |
| Date of Report | 1996-10-02 |
| Report Date | 1996-10-02 |
| Date Mfgr Received | 1996-09-03 |
| Date Added to Maude | 1996-11-12 |
| 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 | 1996-10-02 |
| Model Number | LUNDIA ALPHA 700 |
| Catalog Number | N01849004 |
| Lot Number | 6-0088-L01 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 48429 |
| Manufacturer | GAMBRO HEALTHCARE |
| Manufacturer Address | 1185 OAK STREET LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-10-02 |