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 Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Malaise (2359); Blood Loss (2597)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a 2008t machine's blue dialyzer tubing split.The machine alarmed "blood leak".The patient lost approximately 200ml of blood and felt unwell, dizzy and had low blood pressure.Saline solution was administered and the patient was moved to another machine to complete treatment.

Manufacturer Narrative

A clinical investigation was performed to identify a causal relationship between the hemodialysis (hd) treatment and the adverse event.Based on the provided information there is a possible causal relationship between the hd treatment on the fresenius 2008t machine and patient not feeling well, dizziness and hypotension resulting in administration of saline to the patient.The patient¿s symptoms could be a result of the approximately 200ml blood loss which resulted from the internal fluid leak in the machine.However, these are also common recurrent symptoms experienced during hd therapy.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

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 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.

• 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: 7612060
• MDR Text Key: 111429305
• Report Number: 2937457-2018-01718
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 84