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

Catalog Number 191058

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event 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.

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.

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 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
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• 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: 6681882
• MDR Text Key: 78909978
• Report Number: 2937457-2017-00532
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861102020
• UDI-Public: 00840861102020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 191058
• Device Lot Number: 16061302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 115