MAUDE Adverse Event Report: CONCORD MANUFACTURING CRIT-LINE III BLOODCHAMBER II; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number	191058
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.
Event or Problem Description
It was reported that at least half-way through a patient hemodialysis (hd) treatment with a fresenius 2008k machine, a staff member at the user facility accidently bumped into the crit-line clip device that was attached to the bloodchamber, which loosened the bloodchamber connection to the dialyzer causing an external blood leak.There was visible blood dripping down the dialyzer.The estimated blood loss was approximately 4ml and there was no change in the patient status.The staff re-tightened the connection between the bloodchamber and dialyzer, and the patient was able to complete treatment without any further issues.There was no patient injury or adverse reaction reported and no medical intervention was required.There was no allegation of a defect or malfunction regarding the bloodchamber or dialyzer devices.The nurse reported that the machine may have alarmed, but was unsure.Following the event, the machine was removed from service to be cleaned.The machine has been returned to service without any further issue as reported.The dialyzer was an optiflux f200 or f250, but no further information was able to be provided.No samples are available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Device evaluation: the complaint sample was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A records review of the device manufacturing records could not be performed as the blood chamber lot number was not provided.However, investigation by medica confirmed that no anomalies were recorded during production or quality control processes.The investigation into the cause of the reported problem was not able to be confirmed.
Additional Manufacturer Narrative
Follow-up: device evaluation device evaluation: a follow-up product investigation report was received by medica.A review of production process and quality control (qc) inspections on the bloodchamber part number 191058 was conducted by the manufacturer.All parts are inspected and processed according to approved procedures and dedicated control cards including visual, dimensional, function, and packaging controls.Molded parts are inspected and released by the by the manufacturing based on qc operating instruction.The assembling of the parts is performed through validated automatic assembly equipment, which is subject to periodic maintenance.There are controls in place to confirm the assembling process, including verification of correct bonding between body and dialyzer connector, flow control, leak test, dimensional inspections, presence and correct screwing of the caps on the twist-lock connector and dialyzer connector, and releasing station.All non-conforming units are isolated for scrap destruction.The packaging activities are in compliance with approved operation instruction, including visual and dimensional inspections.Based on medica's review of the manufacturing and inspection of the product, there is no detection of any deviation which could confirm the complaint event.As the complaint sample is not available to be inspected, the complaint cannot be confirmed.The original investigation conclusion stands.Should additional information become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: CRIT-LINE III BLOODCHAMBER II
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7192889
• Report Number: 2937457-2018-00174
• Device Sequence Number: 73213
• Product Code: KOC
• UDI-Device Identifier: 00840861102020
• UDI-Public: 00840861102020
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K160749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 191058
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 03/15/2018; 05/15/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 03/29/2018; 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008K HD MACHINE; FRESENIUS BLOODLINES; FRESENIUS DIALYZER