MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-17 for AQUADEX SYSTEM A1100 114158 manufactured by Gambro Uf Solutions.
[4553600]
Gambro received a voluntary medwatch report that stated a patient with a complex medical history was admitted to the hospital secondary to unexpected weight gain and shortness of breath. Four days after aquapherisis was initiated, the patient? S urine turned a dark maroon color and the ultrafiltrate was pink tinged. The patient may have developed acute kidney injury. The clinical investigation is ongoing. Limited information has been provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[11719350]
Limited information has been provided with regard to this event. It was noted that the ultrafiltrate had a? Pink tint? To it. Ultrafiltrate is normally colorless or a light straw color. Presence of even a small amount of blood gives the ultrafiltrate a bright red color. Pink tint to the ultrafiltrate could indicate that there is some blood leakage into the ultrafiltrate due to a broken fiber in the filter. However, in tests performed to determine the discoloration due to blood leakage, the results demonstrated that a small amount of blood (1-2 ml) in a liter bag of fluid would result in a colormetric change of more than just a tint. The customer has not made the serial number of the console known; therefore, gambro could neither perform a device history record check nor a complaint file check for the console. The customer has not made the lot number of the circuit known; therefore, gambro could neither perform a device history record check nor a complaint history file check for the circuit. This event was originally submitted to fda on (b)(4) 2014 with mfr rpt # 3003504604-2013-00003 which was incorrect. The correct mfr rpt # is 3003504604-2014-00001. Device not returned to mfg; device sn and lot number have not been provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003504604-2014-00001 |
| MDR Report Key | 3757584 |
| Report Source | 05 |
| Date Received | 2014-04-17 |
| Date of Report | 2013-12-30 |
| Date of Event | 2013-12-02 |
| Date Mfgr Received | 2013-12-30 |
| Date Added to Maude | 2014-04-17 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| 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 | 2014-04-17 |
| Model Number | A1100 |
| Catalog Number | 114158 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2014-04-17 |