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

Catalog Number	191058
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2017
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 user facility's nurse manager reported that a blood leak occurred on the blood chamber of the crit-line iii bloodchamber ii device 5-10 minutes after initiation of the patient's hemodialysis (hd) treatment.The leak occurred where the crit-line screws into the head of the dialyzer.No cracks were visible on the crit-line module, the complainant indicated it as being a connection issue.The patient's estimated blood loss (ebl) was noted as being approximately 25 cubic centimeters (cc).The nurse was able to tighten the connection to resolve the issue, and then the hd therapy was continued and successfully completed without any issues.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The crit-line iii bloodchamber ii was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.
Additional Manufacturer Narrative
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.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.
Additional Manufacturer Narrative
Plant investigation: a user facility's nurse manager reported that there was a blood leak on the blood chamber used on the crit-line iii monitor about 5-10 minutes into a patent's treatment.About 25cc of blood was lost.The leak occurred where the crit-line screws into the head of the dialyzer.The connection was tightened to resolve the issue.
Event or Problem Description
A user facility¿s nurse manager reported that a blood leak occurred on the blood chamber of the crit-line iii bloodchamber ii device 5-10 minutes after initiation of the patient¿s hemodialysis (hd) treatment.The leak occurred where the crit-line screws into the head of the dialyzer.No cracks were visible on the crit-line module, the complainant indicated it as being a connection issue.The patient¿s estimated blood loss (ebl) was noted as being approximately 25 cubic centimeters (cc).The nurse was able to tighten the connection to resolve the issue, and then the hd therapy was continued and successfully completed without any issues.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The crit-line iii bloodchamber ii was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.

• 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: 6681882
• Report Number: 2937457-2017-00532
• Device Sequence Number: 16154089
• Product Code: KOC
• UDI-Device Identifier: 00840861102020
• UDI-Public: 00840861102020
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,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 Catalogue Number: 191058
• Device Lot Number: 16061302
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 05/31/2017; 05/15/2018
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 01/31/2018; 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 Weight: 115