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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING CRIT-LINE III BLOODCHAMBER II; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
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CONCORD MANUFACTURING CRIT-LINE III BLOODCHAMBER II; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS Back to Search Results
Catalog Number 191058
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2017
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 administrative assistance reported that a patient experienced blood loss while undergoing hemodialysis (hd) treatment on a (b)(4) hd machine.The following details were provided.The crit-line iii blood-chamber ii device disconnected from the optiflux (b)(4) dialyzer with 15 to 20 minutes left in the hd treatment.The blood within the arterial line of the extracorporeal circuit was returned and the hd therapy was discontinued.The patient's estimated blood loss (ebl) was noted as being approximately 520 milliliters (ml).The patient's condition was fine.No patient adverse effects were experienced and no medical intervention was required as a result of this event.No malfunction of the (b)(4) hd machine was observed or identified, prior to, during, or following the hd treatment.There was no allegation that a bloodline malfunction occurred.The machine, dialyzer, bloodlines, and blood chamber were not available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
The sample is not available for evaluation as it was discarded at the facility.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.Distribution records were reviewed to identify potential lots of this product shipped to the customer.The review included a check of non-conformance's, rework, labeling, process controls, and any other occurrence in production potentially related to the reported complaint.The lot passed all release criteria.
 
Event Description
A user facility's administrative assistance reported that a patient experienced blood loss while undergoing hemodialysis (hd) treatment on a 2008k2 hd machine.The following details were provided.The crit-line iii bloodchamber ii device disconnected from the optiflux f200nr dialyzer with 15 to 20 minutes left in the hd treatment.The blood within the arterial line of the extracorporeal circuit was returned and the hd therapy was discontinued.The patient's estimated blood loss (ebl) was noted as being approximately 520 milliliters (ml).The patient's condition was fine.No patient adverse effects were experienced and no medical intervention was required as a result of this event.No malfunction of the 2008k2 hd machine was observed or identified, prior to, during, or following the hd treatment.There was no allegation that a bloodline malfunction occurred.The machine, dialyzer, bloodlines, and blood chamber were not available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.As the serial number of the alleged blood chamber product was not provided, an investigation of the device manufacturing records could not be conducted by the manufacturer.Please be advised all device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.
 
Event Description
A user facility's administrative assistance reported that a patient experienced blood loss while undergoing hemodialysis (hd) treatment on a 2008k2 hd machine.The following details were provided.The crit-line iii bloodchamber ii device disconnected from the optiflux f200nr dialyzer with 15 to 20 minutes left in the hd treatment.The blood within the arterial line of the extracorporeal circuit was returned and the hd therapy was discontinued.The patient's estimated blood loss (ebl) was noted as being approximately 520 milliliters (ml).The patient's condition was fine.No patient adverse effects were experienced and no medical intervention was required as a result of this event.No malfunction of the 2008k2 hd machine was observed or identified, prior to, during, or following the hd treatment.There was no allegation that a bloodline malfunction occurred.The machine, dialyzer, bloodlines, and blood chamber were not available to be returned to the manufacturer for evaluation.
 
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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 Key6688774
MDR Text Key79131704
Report Number2937457-2017-00539
Device Sequence Number1
Product Code KOC
UDI-Device Identifier00840861102020
UDI-Public00840861102020
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160749
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Catalogue Number191058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age MO
Date Manufacturer Received10/24/2017
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 Number1
Treatment
(B)(4) HD MACHINE (9K0S146197); FRESENIUS BLOODLINES (UNKNOWN); OPTIFLUX 200NR DIALYZER (UNKNOWN)
Patient Age17 YR
Patient Weight98
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