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 Air Leak (1008); No Audible Alarm (1019)

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

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res).The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A user facility nurse reported that the venous chamber would not hold prime at the start of a patient¿s hemodialysis (hd) treatment, allowing air to enter the bloodlines.Prior to the start of hd treatment, the fluid in the venous chamber was dropping, so the nurse filled the lines with saline during priming.When the patient¿s blood was in the venous chamber, it was reported that the blood dropped so low, air had entered the bloodlines.There was no machine alarm.The nurse removed the venous bloodline section and replaced it with another venous line from the same lot number.The nurse stated that the same thing happened where the blood dropped below level, allowing air to enter in the bloodline.The patient¿s blood was not returned from both sets of venous bloodlines and the total estimated blood loss (ebl) was noted as more than 200ml.The patient completed treatment with a set-up of new supplies on a different machine.No patient adverse effects or injuries were experienced, and no medical intervention was required.The patient was able to complete treatment without any further interruptions or complications.The patient¿s hemoglobin was tested after treatment as the patient had a low hemoglobin level prior to the start of treatment, however, no actions were taken regarding the blood loss.The patient continues regularly scheduled hd treatments without issue.The machine was removed from service following the event.The user facility biomedical engineer (biomed) evaluated the machine and confirmed it was functioning properly.The machine was still sequestered pending clinical approval prior to putting back into service.There was no reported defect or crack with either set of bloodlines used.The bloodline device was stated to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.There was no on-site evaluation of the unit performed by a fresenius regional equipment specialist (res).The user facility biomedical technician (biomed) evaluated the machine and confirmed it was functioning properly.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 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
• MDR Report Key: 7240549
• MDR Text Key: 99778578
• Report Number: 2937457-2018-00356
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 02/21/2018
• Supplement Dates FDA Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES
• Patient Age: 60 YR
• Patient Weight: 76