MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

Device Problem Alarm Not Visible (1022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A batch records review was conducted by the manufacturer for the reported serial number.There were no deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history records (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The device met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.

Event Description

A user facility clinical manager reported that the patient care technician (pct) saw discoloration inside the dialyzer dialysate port while rinsing the patient¿s blood.Blood leak test strips were used and came back positive for the presence of blood.The clinical manager stated that the fresenius 2008k2 machine did not alarm and was removed from service.The patient¿s blood was not rinsed back, and patient¿s estimated blood loss was approximately 300 ml.The patient did not experienced any adverse event, injuries or required medical intervention.The clinical manager stated that the dialyzer used was not a fresenius dialyzer, and could not provide the manufacturer.Additionally, the clinical manager stated that there was no blood leak observed from the dialyzer.The clinical manager stated that the in ¿house biomed looked at the machine and reported that no issues were found.The clinical manager stated that the machine has been returned to service without further issues.Additional patient demographics was requested; however not provided.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7559052
• MDR Text Key: 109751351
• Report Number: 2937457-2018-01515
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1