MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1998-03-27 for LUNDIA ALPHA 700 NO1B49004 manufactured by Gambro Healthcare.
[133109]
Pt reaction during treatment. Symptoms: extreme tachycardia. Relieved with o2 at 2 l/min. Dialyzer type changed and treatment resumed. No injury.
Patient Sequence No: 1, Text Type: D, B5
[7774565]
Event description: pt reaction during treatment. Symptoms were: dyspnea flushing. , short breath, hypotensive and chest tightness, benadryl given and treatment discontinued. Treatments resumed with different type of dialyzer. Investigation / determination of cause: the review of device history records does not indicate any deviations during production of the lot. The pt could have demonstrated a hypersensitivity history to a variety of substances including products sterilized with "eto. " the pt had not been on dialysis very long. Safety analysis: users are advised of the possibility of adverse reaction in the instruction for use: extra care must be taken when treating pts for the first three to four weeks with a specific dialyzer, or pts who have exhibited possible hypersensitivity to products sterilized with ethylene oxide, or pts who have a history of being highly sensitive and allergic to a variety of substances. (ifu no 1892) same lot samples were analyzed for residuals. The results were not quantifiable. Follow-up action the possibility of pt reaction due to the complex interaction between blood and the artificial surface of the entire extracorporeal circuit is described. These reactions may also be exacerbated by other external factors involved with the individual pts specific disease process and the treatment of renal insufficiency. The exact cause of the reported event is unknown. Dhr review review of the device history record does not indicate any deviation of during product of the lot. No other reactions complaints have been filed against this lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030992-1998-00001 |
| MDR Report Key | 159488 |
| Report Source | 06,07 |
| Date Received | 1998-03-27 |
| Date of Report | 1998-03-27 |
| Date of Event | 1998-02-13 |
| Date Mfgr Received | 1998-02-25 |
| Date Added to Maude | 1998-03-30 |
| 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 | 0 |
| 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 | 1998-03-27 |
| Model Number | NA |
| Catalog Number | NO1B49004 |
| Lot Number | 7-0014-L01 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 155341 |
| Manufacturer | GAMBRO HEALTHCARE |
| Manufacturer Address | 1185 OAK ST LAKEWOOD CO 80215 US |
| Baseline Brand Name | LUNDIA ALPHA 700 |
| Baseline Generic Name | PLATE DIALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | NO1B49004 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-27 |