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

Model Number	CRIT-LINE III BLOODCHAMBER II
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A registered nurse at the user facility reported that three (3) hours into a four (4) hour treatment, a fresenius crit-line blood chamber completely disconnected from a gambro revaclear dialyzer and 200 cubic centimeters (cc) of blood was lost.Treatment was stopped and the crit-line blood chamber was replaced with a new one.The patient completed treatment without any ill effects, adverse events or medical intervention.The machine was not removed from service following this incident.No samples were available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: the alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation, therefore a root cause of the alleged event could not be determined.
Additional Manufacturer Narrative
Follow up #2: evaluation.
Additional Manufacturer Narrative
All the involved personnel is duly trained and instrument calibration and machine maintenance status is in compliance.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.
Event or Problem Description
A registered nurse at the user facility reported that three (3) hours into a four (4) hour treatment, a fresenius crit-line blood chamber completely disconnected from a gambro revaclear dialyzer and 200 cubic centimeters (cc) of blood was lost.Treatment was stopped and the crit-line blood chamber was replaced with a new one.The patient completed treatment without any ill effects, adverse events or medical intervention.The machine was not removed from service following this incident.No samples were available to be returned to the manufacturer for evaluation.

• 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: 6653966
• Report Number: 2937457-2017-00485
• Device Sequence Number: 19120112
• Product Code: KOC
• UDI-Device Identifier: 00840861102020
• UDI-Public: 00840861102020
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/30/2018

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 Expiration Date: 06/30/2019
• Device Model Number: CRIT-LINE III BLOODCHAMBER II
• Device Catalogue Number: 191058
• Device Lot Number: 16061302
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 06/05/2017; 05/30/2018; 05/30/2018
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 01/31/2018; 05/30/2018; 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 70