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

Catalog Number 190713

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem Cramp(s) (2193)

Event Date 07/10/2018

Event Type  Injury  

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).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A user facility clinical manager reported that the ultrafiltration (uf) goal and treatment time changed on a fresenius 2008k2 hemodialysis (hd) machine after the initiation of the patient's treatment.The machine was programed to a uf goal of 4800ml and treatment time of 3 hours, however, that treatment ended 1 hour early.The clinical manager stated that the machine was manually adjusted back to the original settings using the up/down arrows to decrease the uf goal by 800ml.The uf was not turned off at all during treatment.The patient complained of cramping and was given a one-time dose of zofran (4mg, administered intravenously).It was reported that no additional treatments were required.Additional patient and machine information was requested but was not provided.Treatment records were not provided for this patient and the machine evaluation has not been completed, therefore causality of the adverse event cannot be confirmed.Should additional information become available, a supplement will be filed.

Manufacturer Narrative

There is a possible causal relationship between the patient¿s symptoms of cramping with iv administration of zofran and hd therapy on the 2008t machine.The machine reportedly defaulted to remove 4800ml from the patient and then was reduced during treatment to 4000ml.However, after treatment ended and the patient was weighed it was noted that 5700ml was removed from the patient and that the treatment ended an hour early.Treatment records were not provided for this patient and the machine evaluation has not been completed, therefore causality of the adverse event cannot be confirmed.Should additional information become available, this clinical evaluation will be reassessed.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 7713647
• MDR Text Key: 114821446
• Report Number: 2937457-2018-02098
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 99