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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DASCO SPA PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO DASCO SPA PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number PHOENIX
Device Problems Failure to Conduct (1114); Degraded (1153); Failure to Calibrate (2440); Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2020
Event Type  malfunction  
Event Description
After installing my new sterilant tank on the phoenix unit this morning. I proceeded to try and calibrate the b&a conductivity on the unit. I did this because, this unit has been having all kinds of intermittent conductivity errors. During the calibration, the unit kept on tripping errors, that dialyzer pressures were high and low. After inspecting the pi/pd/pfs pressure transducers, i discovered that the diaphragm in all three of them was damaged/deteriorated rubber. This is not the first unit that i have found this problem on; this is a wide spread problem. Because of this discovery i will need to check every small orifice for clogging. The part # 6990717. I had another pressure transducer go bad on another unit this morning while doing a ph1 inspection this morning. I was unable to test/calibrate pi this morning. When i opened up the pressure transducer it was the same way. Additionally i did another inspection on another unit on monday that was the same way on po. Lately every unit that i am touching has bad transducers. Manufacturer response for hemodialysis unit #3, gambro (phoenix) (per site reporter). Thank you for contacting baxter and reporting about the product complaint pressure transducers with product code: 6990717, wherein, after inspecting the pi/pd/pfs pressure transducers, it was discovered that the diaphragm in all three of them were damaged/deteriorated rubber. Had ended finding the fourth pressure transducer diaphragm that was also deteriorating and possibly blocking other orifices in the hydraulic system. We would like to request additional information related to your report and hoping you can assist us with this request. Would you be able to provide assistance in obtaining the following information: (this is for second follow-up) are the actual samples available to be returned to manufacturing plant for further investigation? we regret any inconvenience this issue may have caused and thank you for bringing this matter to our attention. Baxter healthcare is committed to treating customer complaints seriously and we monitor them closely. We appreciate you taking the time and thank you in advance for your assistance. Manufacturer response for hemodialysis unit, gambro (phoenix) (per site reporter). Thank you for contacting baxter and reporting about the product complaint pressure transducers with product code: 6990717, wherein, after inspecting the pi/pd/pfs pressure transducers, it was discovered that the diaphragm in all three of them were damaged/deteriorated rubber. Had ended finding the fourth pressure transducer diaphragm that was also deteriorating and possibly blocking other orifices in the hydraulic system. We would like to request additional information related to your report and hoping you can assist us with this request. Would you be able to provide assistance in obtaining the following information: (this is for second follow-up). Are the actual samples available to be returned to manufacturing plant for further investigation? we regret any inconvenience this issue may have caused and thank you for bringing this matter to our attention. Baxter healthcare is committed to treating customer complaints seriously and we monitor them closely. We appreciate you taking the time and thank you in advance for your assistance.
 
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Brand NamePHOENIX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO DASCO SPA
one baxter parkway
deerfield IL 60015
MDR Report Key10413295
MDR Text Key203125713
Report Number10413295
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2020
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberPHOENIX
Device Catalogue Number6990717
Device Lot Number6990717
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/11/2020
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer08/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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