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

Model Number 180343

Device Problem Inadequate Ultra Filtration (1656)

Patient Problems Discomfort (2330); Weight Changes (2607); Hypervolemia (2664)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: clinical investigation: there is a temporal relationship between hd therapy utilizing the fresenius 2008t machine and the patient allegation of her post-weight being higher than her pre-weight.However, there is no documentation in the complaint file to show a causal relationship between the use of the machine and the patient weight post-treatment.The hd nurse and patient both reported that there were no issues during the hd treatment and that the treatment was completed.The hd nurse reported there could have been an incorrect pre-weight calculated.Additionally, the patient does receive fluid during the treatment.The patient's allegation and feeling of heaviness resulted in an additional 2-hour non-scheduled dialysis treatment on the following day to remove any additional fluid.This patient did not require any additional medical intervention.Based on the available information and no allegation of a malfunction or deficiency, the fresenius 2008t machine can be excluded as the cause of the patient event.

Event Description

A hemodialysis (hd) patient reported having fluid removed, but more fluid was added on.Scheduled hd treatment on (b)(6) 2021.The patient reported her pre-treatment weight was 97.6kg.The patient underwent hd therapy utilizing the fresenius 2008t machine without issues.After the completion of treatment, the patient stated her post-treatment weight was 98.1kg.The patient did not understand why the weight was higher after her treatment.The hd nurse reported that she explained to the patient the pre-weight could have been incorrect as there are varying factors.The patient is unstable and tends to grab the scale bars at times to steady herself which can affect the scale readings.Also, the patient receives 600ml of fluids with every treatment.The hd nurse stated there were no issue with the patient's treatment.The treatment was completed.Due to the patient complaints of feeling heavy and not being comfortable with the post-weight, the clinic nurse practitioner scheduled the patient to come in for a 2-hour hd treatment on (b)(6) 2021 to remove any additional fluid.No further medical intervention was required.The patient completed the 2-hour treatment.

Event Description

A hemodialysis (hd) patient reported having fluid removed, but more fluid was added on.Scheduled hd treatment on (b)(6)2021.The patient reported her pre-treatment weight was 97.6kg.The patient underwent hd therapy utilizing the fresenius 2008t machine without issues.After the completion of treatment, the patient stated her post-treatment weight was 98.1kg.The patient did not understand why the weight was higher after her treatment.The hd nurse reported that she explained to the patient the pre-weight could have been incorrect as there are varying factors.The patient is unstable and tends to grab the scale bars at times to steady herself which can affect the scale readings.Also, the patient receives 600ml of fluids with every treatment.The hd nurse stated there were no issue with the patient¿s treatment.The treatment was completed.Due to the patient complaints of feeling heavy and not being comfortable with the post-weight, the clinic nurse practitioner scheduled the patient to come in for a 2-hour hd treatment on (b)(6)2021 to remove any additional fluid.No further medical intervention was required.The patient completed the 2-hour treatment.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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.

• Brand Name: 2008T 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: 11369515
• MDR Text Key: 233255528
• Report Number: 2937457-2021-00300
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 180343
• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 94