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

Catalog Number 190766

Device Problem Air Leak (1008)

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

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A hemodialysis (hd) patient's clinic biomedical engineer (biomed tech) reported during hd treatment the technician noticed air in blood line approximately one minute into treatment.No alarm was noted.The air was noted to have passed the occlusion clamp around the needle area.No external leaks were noted.The patient was removed from machine and blood was not returned to patient.The patient's blood loss was 300 ml.The hd patient was unable to complete hd treatment, was sent to the emergency room, evaluated and released.The patient returned to the clinic the following day per doctor's order and completed hd treatment the following day.The on-call physician requested the machine to have air detector recalibrated and an occlusion test was performed and completed.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

A hemodialysis (hd) patient's clinic biomedical engineer (biomed tech) reported during hd treatment the technician noticed air in blood line approximately one minute into treatment.No alarm was noted.The air was noted to have passed the occlusion clamp around the needle area.No external leaks were noted.The patient was removed from machine and blood was not returned to patient.The patient's blood loss was 300ml.The hd patient was unable to complete hd treatment, was sent to the emergency room, evaluated and released.The patient returned to the clinic the following day per doctor's order and completed hd treatment the following day.The on-call physician requested the machine to have air detector recalibrated and an occlusion test was performed and completed.

• 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: 7099524
• MDR Text Key: 95078900
• Report Number: 2937457-2017-01309
• 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,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2016
• 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
• Patient Age: 26 YR
• Patient Weight: 90