MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190766

Device Problems Disconnection (1171); No Fail-Safe Mechanism (2990); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Dyspnea (1816); Exsanguination (1841); Confusion/ Disorientation (2553); Blood Loss (2597)

Event Date 10/27/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

A user facility clinical manager (cm) reported that a patient expired following hemodialysis (hd) treatment.Seventeen minutes after the initiation of the patient¿s hemodialysis (hd) treatment, it was discovered that the prescribed blood flow rate (bfr) could not be achieved.The machine, a fresenius 2008t machine, did not alarm.Staff reversed the patient¿s bloodlines in an effort to improve the patient¿s bfr, and a hemaclip was applied to the arterial lumen and venous bloodline of the patient¿s hd catheter; the treatment was restarted.At approximately 15:30, the patient was observed having difficulty breathing and was visibly pale, and blood was noted on the patient¿s right finger.The patient¿s catheter ports were clamped and a saline bolus was administered.Although it is unknown if the hemaclip was attached to the catheter or the bloodline, it was confirmed that the hemaclip did not pose any imposition while the saline bolus was administered to the patient.It was noted that the venous bloodline separated from the arterial lumen of the patient¿s permanent hd catheter (not a fresenius product).It was confirmed that emergency medical services (ems) were called and cardiopulmonary resuscitative (cpr) was initiated.The patient expired in the emergency room at approximately 16:16.Additional information regarding the patient and the event was requested; however, not provided by the facility.The hospital declined to provide the patient¿s records to the clinic.Upon follow up, it was confirmed that the clinic did not contact the catheter manufacturer to confirm that the hemaclip was compatible with the patient¿s catheter type.It was also confirmed that the patient¿s catheter dressing was changed and that chloroprep was used at the catheter site.It was reported that the devices involved were discarded and there are no parts available for manufacturer evaluation.

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.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 8190454
• MDR Text Key: 131186354
• Report Number: 2937457-2018-03724
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/07/2018,01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2018
• Distributor Facility Aware Date: 10/27/2018
• Device Age: 1 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/08/2018
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS GRANUFLO DIALYSIS CONCENTRATE; FRESENIUS HEMACLIP; FRESENIUS NATURALYTE DIALYSIS CONCENTRATE
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 44