MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-03-27 for LUNDIA ALPHA 700 N01849004 manufactured by Gambro Healthcare.
[95909]
Patient reaction. Symptoms: short of breath, hypotensive and had chest tightness. Given benadryl and o2. No injury.
Patient Sequence No: 1, Text Type: D, B5
[20445351]
Event description: pt complained of feeling of extreme tachycardia. Relieved with o2. Symptoms decrease as dialysis continues. Investigation / determination of cause: the review of device history records does not indicate any deviations during production of the lot. The complaint records were reviewed and no other hypersensitivity reactions were reported. The exact cause of the reported event is unknown. The pt recovered within a few minutes with administration of oxygen. 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 symptoms during previous treatments or pts known or suspected 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 1982) same lot samples were analyzed for residuals. The results were not quantifiable. Follow-up action: the exact cause of the event is unknown. No further action is planned. 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 | 8030992-1998-00002 |
| MDR Report Key | 159486 |
| Report Source | 05,06 |
| 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 | N01849004 |
| 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 | 155339 |
| 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 | N01849004 |
| Baseline ID | ALPHA 700 |
| Baseline Device Family | ALPHA 700 |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K915504 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-27 |