POLYFLUX RVCIR MAX - 1490

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-03 for POLYFLUX RVCIR MAX - 1490 manufactured by Gambro/baxter.

Event Text Entries

[71881536] On (b)(6) ((b)(6) 2013), my father ronald curl went for his first dialysis treatment. At (b)(6). He returned on (b)(6), and (b)(6) 2013). Little did we know, this would be his third and final treatment. On ((b)(6) 2013), he was feeling well enough to visit us at our home. He and my mother arrived around 1:30 in the afternoon. Around 5:00 in the evening they were getting ready to leave. Mama had gone to the restroom, and daddy was sitting on the couch talking to us. He stopped mid-sentence, and both of his arms went up in a jerky uncontrolled motion. I asked him, "daddy are you alright", but he never responded. Mama returned from the restroom and i said "there's something wrong with daddy. Call 911". My husband placed the call around 5:05 pm. The ambulance arrived about 18 minutes later. The paramedic said he didn't have a pulse, and began performing cpr. He then asked if we wanted everything done, and mama said yes. They moved him to the ambulance to continue cpr. We arrived at (b)(6) before the ambulance. When they arrived we were told he was deceased. The death certificate cites sudden cardiac arrest as the cause of death. We had been involved with fresenius since 2014. We were represented by the (b)(6). We have recently learned that granuflo and naturalyte were not used at the (b)(6) where daddy received dialysis. I began researching recalls and recent medications prescribed to daddy. I had no idea how confusing and difficult it is to compare ndcs, product codes, and lot, machine, and item numbers. During my research i found this form, so i apologize for the time gap. The fda's responsibility is to protect people from harmful drugs and medical devices, as well as poorly managed clinics. The fda (medwatch voluntary reporting agency) should be using their knowledge and resources to monitor the drugs, devices, and clinics. That is why i've highlight gambro poly flux rv clear max 1490. It's involved in an ongoing class ii recall (#z-0370-2017). Renvela drug 2. 4 gm power packets was prescribed to my daddy on (b)(6) 2013. This was a new medication for him, and he died four days after he began taking it. On behalf of the (b)(6) family we would appreciate any help in finding closure. The way we lost my daddy will be forever etched in my memory. Sincerely, (b)(6). Who was using it: a health professional: (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5068884
MDR Report Key6459732
Date Received2017-04-03
Date of Report2017-03-27
Date of Event2013-06-08
Date Added to Maude2017-04-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NamePOLYFLUX
Generic NameDIALYZER
Product CodeKDI
Date Received2017-04-03
Model NumberRVCIR MAX - 1490
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerGAMBRO/BAXTER

Device Sequence Number: 1

Brand NamePOLYFLUX
Generic NameDIALYZER
Product CodeKDL
Date Received2017-04-03
Model NumberRVCIR MAX - 1490
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerGAMBRO/BAXTER

Device Sequence Number: 2

Brand NamePOLYFLUX
Generic NameDIALYZER
Product CodeKDL
Date Received2017-04-03
Model Number2IR-1030
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerGAMBRO/BAXTER

Device Sequence Number: 3

Brand NamePOLYFLUX
Generic NameDIALYZER
Product CodeKDL
Date Received2017-04-03
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerGAMBRO/BAXTER


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2017-04-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.