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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEMAMETRICS CRIT-LINE BLOOD CHAMBER
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HEMAMETRICS CRIT-LINE BLOOD CHAMBER Back to Search Results
Lot Number 14061301
Device Problems Device-Device Incompatibility (2919); Improper Flow or Infusion (2954)
Patient Problem Anemia (1706)
Event Date 08/27/2014
Event Type  Injury  
Event Description
Pt presented for treatment on (b)(6) 2014.Treatment initiated using av graft to left upper leg.Pt ran for approx 1 hour and 30 mins.Pt became very pale and alerted staff that she was feeling weak.Vital signs assessed and saline given.At this time blood was found to be leaking from the crit line connection to the dialyzer.Threading was intact and no cracks were identified on the crit line.A large pool of blood was in the floor; 911 was called, pt's physician was notified and reported to the clinic.Pt was given saline and vital signs were stable.Pt was taken to (b)(6) with a hgb of 9.1 and later transported to (b)(6) hospital.Pt remained hospitalized for two days and given three units of blood.
 
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Brand Name
CRIT-LINE BLOOD CHAMBER
Type of Device
CRIT-LINE
Manufacturer (Section D)
HEMAMETRICS
695 north 900 west
kaysville UT 84037 411
MDR Report Key4136412
MDR Text Key4796727
Report Number4136412
Device Sequence Number1
Product Code KOC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2017
Device Lot Number14061301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/27/2014
Device Age2 MO
Event Location Outpatient Treatment Facility
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BLOOD LINE USED: MEDISYSTEMS STREAM LINE -; DIALYSIS MACHINE 2008K; AIRLESS SYSTEM SET; DIALYZER USED: FRESENIUS F160 NR OPTIFLUX DIALYZER
Patient Outcome(s) Hospitalization;
Patient Age36 YR
Patient Weight64
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