MAUDE Adverse Event Report: CONCORD MANUFACTURING UNKNOWN-2008; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- 2008 MACHINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fever (1858)

Event Date 01/01/2020

Event Type  Injury  

Event Description

During a customer experience survey a patient reported they were running a fever as high as 102 after dialysis.The patient stated they told the staff, the nurses and the doctor, that comes in once a month, and all they could said is that the patient probably had an infection.The patient reported they went to their primary care and had tests done that came back negative.The patient reported they found a medical journal publication that identified their problem as fever of unknown origin in dialysis patients.The patient reported to their doctor about it and suggested that it could be a sensitivity to the formula.Their doctor changed the formula and the patient reported they have no more fevers.The patient reported they went through around six months of feeling terrible most of the night after dialysis.The patient reported they have been working out with physical therapy and increasing their protein, the patient stated they put on weight, but the therapy works from their lower weight and the machine is set to take off higher amounts which often makes them nauseous, cramp and their blood pressure go very low.No medical intervention was reported regarding the nausea, cramping, and low blood pressure.Upon follow up the clinic reported the patient is now on home therapy and they had no further information.Additional information was requested, however to date has not been provided.

Manufacturer Narrative

Clinical review: there was no specific allegation this event was due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Multiple attempts were made to acquire further details concerning these events; however, no additional information was obtained.In the intake, it was stated the patient was determined to be negative for infection through tests conducted by their healthcare provider (stated as pc in the survey).Additionally, the patient reported their fevers were determined to be a sensitivity to their [hd] formula and their prescription was changed, resulting in a resolution of symptoms.It can be concluded the patient¿s fevers following hd therapy were attributed to an inherent physiological response to their previous hd prescription and not due to the performance of any fresenius product(s) or device(s).Presently, there is no allegation or objective evidence indicating a serious injury, patient death, or other adverse event(s) occurred related to a fresenius product(s) or device(s) warranting further investigation.Additionally, there is no allegation a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the patient¿s adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted. .

Event Description

During a customer experience survey a patient reported they were running a fever as high as 102 after dialysis.The patient stated they told the staff, the nurses and the doctor, that comes in once a month, and all they could said is that the patient probably had an infection.The patient reported they went to their primary care and had tests done that came back negative.The patient reported they found a medical journal publication that identified their problem as fever of unknown origin in dialysis patients.The patient reported to their doctor about it and suggested that it could be a sensitivity to the formula.Their doctor changed the formula and the patient reported they have no more fevers.The patient reported they went through around six months of feeling terrible most of the night after dialysis.The patient reported they have been working out with physical therapy and increasing their protein, the patient stated they put on weight, but the therapy works from their lower weight and the machine is set to take off higher amounts which often makes them nauseous, cramp and their blood pressure go very low.No medical intervention was reported regarding the nausea, cramping, and low blood pressure.Upon follow up the clinic reported the patient is now on home therapy and they had no further information.Additional information was requested, however to date has not been provided.

• Brand Name: UNKNOWN-2008
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14877676
• MDR Text Key: 295116372
• Report Number: 0002937457-2022-01096
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- 2008 MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention