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

Catalog Number UNKNOWN-2008K MACHINE

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem Loss of consciousness (2418)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A hemodialysis (hd) patient reported via social media that they experienced difficulties with cramping, blacking out at the start of treatment.At the end of treatment, the patient reported that their weight was lower than the targeted weight.The patient reported that a biomed technician figured out that rinse should not be added to the target amount.It is unknown whether the patient was able to complete treatment on the same machine, and the patient experienced fluctuations in weight, cramping and loss of consciousness as a result of this incident.No additional information was provided or was available.

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).A records review and an investigation of the device manufacturing records could not be performed, as no serial number was provided.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Clinical investigation: while a temporal relationship between hemodialysis (hd) treatment with the fresenius 2008k machine and the patient¿s symptoms of cramping and loss of consciousness exists, there is no allegation or documentation that indicates a fresenius product deficiency or malfunction was associated with the patient¿s adverse event.It is conceivable the patient¿s cramping and loss of consciousness was related to adding in the saline rinse to the patient¿s target fluid removal goal which may have resulted in excessive ultrafiltration.

• 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: 7872373
• MDR Text Key: 120117761
• Report Number: 2937457-2018-02708
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN-2008K MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1