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

Model Number 2008K MACHINE

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

Patient Problem Loss of consciousness (2418)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .

Event Description

During follow up for a separate event, it was reported the patient was hospitalized for ¿passing out¿, possibly due to electrolyte imbalance. Upon follow up, the pdrn reported that the patient was already hospitalized (date unknown) for a separate issue unrelated to dialysis. The patient was permanently transitioned to hemodialysis (hd) as a result of that issue. During that hospitalization, the patient passed out during hemodialysis treatment (unknown time into treatment) on the fresenius 2008k machine. Patient vitals and treatment information are unknown. The event could have been caused by an electrolyte imbalance (unspecified) as initially reported. It is unknown what treatment the patient received or if the hd treatment was completed. No additional information was obtained.

Manufacturer Narrative

There is a temporal relationship between the patient event of passing out and hd treatment on the 2008k machine. There is no documentation to show a causal relationship between the adverse event and the 2008k machine. Additionally, there are no reported allegations of malfunction or deficiency against the 2008k machine. Based on the available information a cause of the reported adverse event cannot be determined.

Manufacturer Narrative

The device was not returned. The serial number is unknown. A search of the devices history could not be performed.

• Brand Name: 2008K MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7841548
• MDR Text Key: 119030218
• Report Number: 2937457-2018-02563
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 2008K MACHINE
• Device Catalogue Number: UNKNOWN- 2008K MACHINE
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 09/04/2018 Patient Sequence Number: 1

Treatment

DELFLEX PD SOLUTION; LIBERTY CYCLER SET; DELFLEX PD SOLUTION; LIBERTY CYCLER SET