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 1996-10-11 for LUNDIA ALPHA 700 NO1849004 manufactured by Gambro Healthcare.
[23263]
During a dialysis treatment, there was an external blood leak at the sealing plug at the front of the dialyzer, above the label. The blood in the circuit was lost. There was no pt injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[7760428]
The affected product was discarded by the facility and therefore, is unavailabel fro analysis. Without the affectedf product,it is difficult to determine the exact cause fof the reported problem. The hazard ti ot safety of an external blood leak is directly related to the vaolume of the blood loss and the pt's current or past clinical history. Based on retrospective review ot external blood leak complaints, there is a low likelihood that loss of the extracorporeal blood circuit will reuslt in an injury. In addition, the blood loss, as in this case, is minimal. Without the affected product for investigation, it is difficult for the mfr to determine the exact naute of the reported problem. However, the mfr will continue to monitor and trend. No further reporting is anticipated. A review fo the device history records for the reported lot indicatesf that the lot was manufactured according to mfr's specifications. Customer contacted: no, sales/service coantacted by investigator: no, training required: no.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030992-1996-00008 |
| MDR Report Key | 42897 |
| Report Source | 05,06,07 |
| Date Received | 1996-10-11 |
| Date of Report | 1996-10-11 |
| Date of Event | 1996-09-11 |
| Date Facility Aware | 1996-09-11 |
| Report Date | 1996-10-11 |
| Date Mfgr Received | 1996-09-14 |
| Date Added to Maude | 1996-10-21 |
| 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 | 1996-10-11 |
| Model Number | LUNDIA ALPHA 700 |
| Catalog Number | NO1849004 |
| Lot Number | 6-0087-I01 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 43875 |
| Manufacturer | GAMBRO HEALTHCARE |
| Manufacturer Address | 1185 OAK ST LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-10-11 |