MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-03-21 for AQUADEX SYSTEM A1100 manufactured by Gambro Uf Solutions.
[4292878]
A patient was diagnosed with hemolysis several hours after initiating ultrafiltration therapy. The patient was anticoagulated and had an acute onset of reddish brown urine. The therapy was discontinued and the patient? S symptoms resolved the same day. The cause of the hemolysis is unknown.
Patient Sequence No: 1, Text Type: D, B5
[11593319]
The a1100 console has not been returned for investigation. A device history record investigation has determined that the a1100 console meets specification and there are no other complaints associated with the device. A device history record investigation has determined that the a1650 circuit meets specification. There are no other complaints associated with this lot number. Gambro does not regard the submittal of this report as an admission of causation or liability.
Patient Sequence No: 1, Text Type: N, H10
[17091496]
The company completed the technical investigation on the console and circuit. The console technical investigation concluded that there was no product malfunction. The device continues to meet its performance specifications and performs as intended. There are no other complaints associated with this device s/n. The visual inspection was completed on the returned circuit and found no anomalies. The circuit device history review found that the product meets specification. There are no other complaints associated with this product lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003504604-2014-00002 |
| MDR Report Key | 3693192 |
| Report Source | 07 |
| Date Received | 2014-03-21 |
| Date of Report | 2014-03-21 |
| Date of Event | 2014-02-19 |
| Date Mfgr Received | 2014-02-20 |
| Device Manufacturer Date | 2011-09-08 |
| Date Added to Maude | 2014-03-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS SCAVOTTO |
| Manufacturer Street | 7601 NORTHLAND DRIVE SUITE 170 |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7634634621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUADEX SYSTEM |
| Generic Name | CATHETER, HEMODIALYSIS, NON-IMPLANTED, ULTRAFILTRATION, FOR PERIPHERAL USE |
| Product Code | NQJ |
| Date Received | 2014-03-21 |
| Model Number | A1100 |
| Lot Number | 880 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO UF SOLUTIONS |
| Manufacturer Address | 7601 NORTHLAND DRIVE SUITE 170 BROOKLYN PARK MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-21 |