MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-11-20 for AQUADEX SYSTEM A1100/A1650 114158/114157 manufactured by Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use.
[18732721]
Gambro received a voluntary medwatch report that stated a patient with a complex medical history was admitted to the hospital for acute systolic heart failure. Four days after aquapherisis was initiated, the patient's urine turned a dark red brown color and the ultrafiltrate was pink tinged. The medical team discontinued aquapherisis and started the patient on dialysis.
Patient Sequence No: 1, Text Type: D, B5
[19011003]
Additional manufacturer narrative: limited information has been provided with regard to this event. A device history record investigation for a1100 console s/n (b)(4) determined that the console meets specification. The lot number of the circuit is currently unknown; therefore, gambro could neither perform a device history record investigation nor a complaint history file check for the circuit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003504604-2014-00004 |
| MDR Report Key | 4283341 |
| Report Source | 07 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-08-19 |
| Date Mfgr Received | 2014-10-21 |
| Device Manufacturer Date | 2003-03-01 |
| Date Added to Maude | 2014-12-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS SCAVOTTO |
| Manufacturer Street | 7601 NORTHLAND DR. STE. 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 |
| Product Code | NQJ |
| Date Received | 2014-11-20 |
| Model Number | A1100/A1650 |
| Catalog Number | 114158/114157 |
| Lot Number | 246/UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CATHETER, HEMODIALYSIS, NON-IMPLANTED, ULTRAFILTRATION, FOR PERIPHERAL USE |
| Manufacturer Address | 7601 NORTHLAND DR. STE. 170 BROOKLYN PARK MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-20 |