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 Problems High Blood Pressure/ Hypertension (1908); Syncope/Fainting (4411)

Event Date 01/01/2021

Event Type  Injury  

Event Description

A reddit social media user reported experiencing a syncopic episode while attempting to weigh out at the end of treatment after dialyzing on an unspecified fresenius 2008 hemodialysis (hd) machine.The user reported difficulty with getting their blood pressure up and getting stabilized, which resulted in a trip to the emergency room (er) and being treated with midocrine on dialysis days.The user also noted in their social media post that their blood pressure has recently been increasing (hypertension) during dialysis.Due to the anonymous nature of this social media post, follow up was not possible as no patient information, clinic identification or product(s) serial number was provided in the posting.There was no specific allegation these events were due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is no indication from the provided information that these events were related 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 syncope, blood pressure complications or emergency department visit.

Event Description

A reddit social media user reported experiencing a syncopic episode while attempting to weigh out at the end of treatment after dialyzing on an unspecified fresenius 2008 hemodialysis (hd) machine.The user reported difficulty with getting their blood pressure up and getting stabilized, which resulted in a trip to the emergency room (er) and being treated with midocrine on dialysis days.The user also noted in their social media post that their blood pressure has recently been increasing (hypertension) during dialysis.Due to the anonymous nature of this social media post, follow up was not possible as no patient information, clinic identification or product(s) serial number was provided in the posting.There was no specific allegation these events were due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.

Manufacturer Narrative

Correction: h6 (health effect clinical code, addition of hypertension/high blood pressure).

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.A causal relationship between the objective evidence and the alleged event could not be determined; therefore the alleged event is unconfirmed.A definitive conclusion regarding the reported incident could not be reached.

Event Description

A reddit social media user reported experiencing a syncopic episode while attempting to weigh out at the end of treatment after dialyzing on an unspecified fresenius 2008 hemodialysis (hd) machine.The user reported difficulty with getting their blood pressure up and getting stabilized, which resulted in a trip to the emergency room (er) and being treated with midocrine on dialysis days.The user also noted in their social media post that their blood pressure has recently been increasing (hypertension) during dialysis.Due to the anonymous nature of this social media post, follow up was not possible as no patient information, clinic identification or product(s) serial number was provided in the posting.There was no specific allegation these events were due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.

• 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: 15412544
• MDR Text Key: 299797250
• Report Number: 0002937457-2022-01501
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• 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
• Date Manufacturer Received: 10/06/2022
• 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