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

Catalog Number UNKNOWN- 2008K MACHINE

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

Patient Problems Weakness (2145); Malaise (2359); Neck Pain (2433); Shaking/Tremors (2515)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there were no recorded issues with any fresenius device/ product in relation to the event.No further information is currently available.Weakness and fatigue are not uncommon symptoms experienced by patients with renal failure and long-term dialysis patients; estimates affecting from 42% to 89% of patients.This is often due to many potential etiologies including but not limited to, physiologic aspects of renal failure, concomitant comorbid conditions, and side effects from the hd treatment itself.Moreover, it is not uncommon for patients to change dialysis modality to improve these symptoms and quality of life.Based on the available information, there is no reported allegation objective evidence that a fresenius device or product issue caused or contributed to a serious patient harm or injury.

Event Description

A hemodialysis (hd) patient stated at their doctor's suggestion, to start peritoneal dialysis (pd) dialysis a couple of weeks ago (exact date unspecified).The patient reported they loved that they did not have to get stuck with needles anymore.The patient also stated that they suffer from degenerative disc disease (ddd) and spinal stenosis.The patient stated sitting in a chair for 3+ hours was very hard on their neck and back.Additionally, i the patient reported they often felt sick, weak and shaky after a treatment.It has been less than 2 weeks since the patient started home dialysis and they feel much better already.Upon follow-up, the patient stated that they did not know how the equipment malfunctioning would cause them to feel "bad".The patient stated that they think that the treatment (removing blood and returning it after cleaning it) is an unnatural procedure and is hard on a person's body.The patient had their fluid intake at optimum levels and their lab work show levels that were in good range.The patient believed that because they were losing weight, they may have been over-dialyzed which was causing them to feel sick.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res) 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. .

• Brand Name: 2008K MACHINE
• 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
• MDR Report Key: 9700181
• MDR Text Key: 179234125
• Report Number: 2937457-2020-00297
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

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- 2008K MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention