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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMISSON-CARTLEDGE BIOMEDICAL, LLC SMISSON-CARTLEDGE BIOMEDICAL, LLC; THERMACOR 1200 INFUSION SYSTEM
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SMISSON-CARTLEDGE BIOMEDICAL, LLC SMISSON-CARTLEDGE BIOMEDICAL, LLC; THERMACOR 1200 INFUSION SYSTEM Back to Search Results
Model Number PNC-1200
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/21/2015
Event Type  malfunction  
Event Description
The thermacor 1200 infusion system was being used at (b)(6) hosp on (b)(6) 2015.The hosp stated that the cassette started leaking, and they changed over to a level one unit.However, the hosp bio-med investigated the issue and found the operator had not loaded the tubing correctly into the pump door area and the roller pump door had pinched the tubing, causing the leakage.No pt injury or extended surgery time was needed for changing out the unit.In-service training is being conducted on 5/1/2015 to ensure the operators understand proper loading of the cassette.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
SMISSON-CARTLEDGE BIOMEDICAL, LLC
Type of Device
THERMACOR 1200 INFUSION SYSTEM
Manufacturer (Section D)
SMISSON-CARTLEDGE BIOMEDICAL, LLC
macon GA
Manufacturer Contact
487 cherry st
macon, GA 31201
4787449992
MDR Report Key4752406
MDR Text Key5890313
Report Number3006158088-2015-00002
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/30/2015
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
Device Operator Health Professional
Device Model NumberPNC-1200
Device Catalogue NumberPNC-1200
Device Lot Number431129058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/30/2015
Initial Date FDA Received05/04/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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