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 Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
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 there was a blood leak occurred on the blood chamber of the crit-line iii blood chamber 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 iii module, the complainant indicated it as being a connection issue.The patient's estimated blood loss (ebl) was noted as being approximately 25-50 cubic centimeters (cc).The nurse attempted to re-seat the crit-line iii module without success.The patient was re-set up with a new bloodline, dialyzer, and blood chamber, 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 blood chamber ii and the optiflux dialyzer assembly were not available to be returned to the manufacturer for evaluation as both devices were discarded by the user facility.
Event or Problem Description
A user facility's nurse manager reported that there was a blood leak occurred on the blood chamber of the crit-line iii bloodchamber ii device halfway through a 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 iii module, the complainant indicated it as being a connection issue.The patient's estimated blood loss (ebl) was noted as being approximately 25-50 cubic centimeters (cc).The patient was re-set up with a new bloodline, dialyzer, and blood chamber, 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 complaint device was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.
Additional Manufacturer Narrative
Plant investigation: nurse manager reported that there was a blood leak on the blood chamber used on the crit-line iii monitor 2 hours into a patient's treatment.The leak occurred where the crit-line screws into the head of the dialyzer.No cracks were visible and about 25-50cc of blood was lost.As the lot number not available; review of the history could not be performed.
Event or Problem Description
A user facility's nurse manager reported that there was 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 iii module, the complainant indicated it as being a connection issue.The patient's estimated blood loss (ebl) was noted as being approximately 25-50 cubic centimeters (cc).The nurse attempted to re-seat the crit-line iii module without success.The patient was re-set up with a new bloodline, dialyzer, and blood chamber, 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 and the optiflux dialyzer assembly were not available to be returned to the manufacturer for evaluation as both devices were discarded by the user facility.
Event or Problem Description
A user facility's nurse manager reported that there was a blood leak occurred on the blood chamber of the crit-line iii blood chamber ii device halfway through a 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 iii module, the complainant indicated it as being a connection issue.The patient's estimated blood loss (ebl) was noted as being approximately 200 milliliters (ml).The patient was re-set up with a new bloodline, dialyzer, and blood chamber, 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 complaint device was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.
Additional Manufacturer Narrative
Corrected date of event: (b)(6) 2017 corrected describe event or problem corrected.Occupation: health professional plant investigation: nurse manager reported that there was a blood leak on the blood chamber used on the crit-line iii monitor 2 hours into a patient's treatment.The leak occurred where the crit-line screws into the head of the dialyzer.No cracks were visible and about 25-50 cc of blood was lost.As the lot number not available; review of the history could not be performed.

• 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: 6641340
• Report Number: 2937457-2017-00464
• Device Sequence Number: 16356085
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/22/2018

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 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: 05/15/2017
• Supplement Date Received by Manufacturer: 07/12/2017; 02/20/2018; 02/22/2018
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 01/31/2018; 02/20/2018; 02/22/2018
• 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 OPTIFLUX 180NRE DIALYZER
• Patient Weight: 95