MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-08-28 for DIACIDE DIALYZER UNK 3545 manufactured by Alden, A Division Of Metrex Research Corporation.
[217343]
The dr from the facility reported that upon the onset of dialysis a pt experienced low blood pressure, shortness of breath, and perioral numbness. The clinician discontinued dialysis upon noticing the reactions. The pt rec'd medical attention and was prescribed dopamine. The pt's blood pressure returned to normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221361-2001-00004 |
| MDR Report Key | 349262 |
| Report Source | 05 |
| Date Received | 2001-08-28 |
| Date of Report | 2001-07-26 |
| Date of Event | 2001-07-25 |
| Date Mfgr Received | 2001-07-26 |
| Date Added to Maude | 2001-08-31 |
| 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 |
| Manufacturer Contact | WENDY URTEL |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167425 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIACIDE DIALYZER |
| Generic Name | DISINFECTANT FOR DIALYZERS |
| Product Code | FKQ |
| Date Received | 2001-08-28 |
| Model Number | UNK |
| Catalog Number | 3545 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 338579 |
| Manufacturer | ALDEN, A DIVISION OF METREX RESEARCH CORPORATION |
| Manufacturer Address | 360 COLD SPRING AVENUE WEST SPRINGFIELD MA 01089 US |
| Baseline Brand Name | DIACIDE DIALYZER |
| Baseline Generic Name | STERILANT/DISINFECTANT FOR DIALYZERS |
| Baseline Model No | UNK |
| Baseline Catalog No | 3545 |
| Baseline ID | NA |
| Baseline Device Family | DIALYSATE DELIVERY SYSTEM SOLUTION |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K822535 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2001-08-28 |