MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-08-14 for AQUADEX SYSTEM A1100-03 114158 manufactured by Gambro Uf Solutions.
[17462176]
A patient in (b)(6) was undergoing aquapherisis treatment on an aquadex machine in conjunction with a b braun fm perfusor pump and a b braun 50 ml perfusor syringe used for an ongoing infusion of heparin. The perfusor pump was connected to the withdraw access port on the extracorporeal circuit. The perfusor pump generated an alarm at which time the user found the syringe of heparin (containing approximately 20 ml heparin) emptied and 10,000 iu of heparin was administered to the patient instead of the intended 1,000 iu/hourly infusion. According to the healthcare provider, the perfusor syringe was not properly seated and locked in the perfusor pump which resulted in the unintended emptying of the heparin syringe. The patient was not symptomatic as a result of unintended heparin dosage. The patient was administered 3500 iu of protamine sulfate to reverse the anticoagulant effect of the heparin.
Patient Sequence No: 1, Text Type: D, B5
[17741225]
The a1100 aquadex console will not be returned for evaluation because there are no data that suggests an a1100 aquadex system malfunction occurred. An a1100 aquadex console device history record investigation has determined that the a1100 aquadex console meets specification and there are no other complaints associated with the device. The a1100 aquadex console operated as intended; there was no malfunction or alleged device malfunction. The event was directly related to the healthcare professional's connection of the b braun 50 ml perfusor syringe in the b braun fm perfusor pump perfuser; this event is considered user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003504604-2013-00002 |
| MDR Report Key | 3288190 |
| Report Source | 07 |
| Date Received | 2013-08-14 |
| Date of Report | 2013-07-18 |
| Date of Event | 2013-07-13 |
| Device Manufacturer Date | 2012-12-19 |
| Date Added to Maude | 2013-08-15 |
| 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 | 2013-08-14 |
| Model Number | A1100-03 |
| Catalog Number | 114158 |
| Lot Number | 4057 |
| 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 | 2013-08-14 |