MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-03-27 for LUNDIA ALPHA 700 ALPHA 700 HG N01849004 manufactured by Gambro Healthcare.
[51194]
An external blood leak was found during a dialysis treatment. There was no pt injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[15229250]
Investigation defective dialyzer was not available for analysis so exact cause of failure could not be determined. According to info in complaint, leak occurred at sealing plug on front of dialyzer. Based on this info it can be concluded that leak most probably was caused by a defective or damaged sealing plug. Safety analysis hazard to pt safety of an external blood leak is directly related to volume of blood loss and pt current/past clinical history. Based on retrospective review of external blood leak complaints due to sealing plug leakage, there is a low likelihood that loss of the extracorporeal blood circuit will result in a serious injury. Defective or damaged sealing plug normally causes a minimal leak of blood droplets and in no case a sealing plug leak has resulted in any massive blood leak. Follow-up action 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. Activities on plugging station were done on 10/3/96. Adjustments of complete plugging station have earlier been rechecked on 8/9/96. As part of a continuing improvement program moulding tool for plug was plished to avoid any occurrence of surface roughness. This action implemented 9/2/96 will facilitate movement of plug in plug station and reduce any possibilities for random damages to plug. Lot was produced 8/23/96. Review of lot history files do not indicate any deviation during production of this lot. A review of complaint file for lot indicates that there is 1 more reported complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030992-1997-00002 |
| MDR Report Key | 80462 |
| Report Source | 04 |
| Date Received | 1997-03-27 |
| Date of Report | 1997-02-27 |
| Date of Event | 1997-02-06 |
| Date Mfgr Received | 1997-02-27 |
| Date Added to Maude | 1997-04-03 |
| 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 | RL |
| 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 | 1997-03-27 |
| Model Number | ALPHA 700 HG |
| Catalog Number | N01849004 |
| Lot Number | 6-0119-I01 |
| 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 | 79930 |
| Manufacturer | GAMBRO HEALTHCARE |
| Manufacturer Address | 1185 OAK STREET LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-27 |