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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG ULRICHINJECT CT MOTION PEDESTAL VERSION

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ULRICH GMBH & CO. KG ULRICHINJECT CT MOTION PEDESTAL VERSION Back to Search Results
Model Number XD 8000-001
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/28/2019
Event Type  malfunction  
Manufacturer Narrative
The company did not initially believe the event to be reportable to fda because there was no injury to the patient and the device did not malfunction. Upon further investigation, the company determined the event to be reportable and the decision was made to submit despite being past the 30 day deadline.
 
Event Description
The ct motion was serviced on (b)(6) 2019 and on completion, the technician changed the program to a 1. 5 m patient tubing set, however, the reporter routinely uses a 2. 5 m patient tube. The user started the injection with a 2. 5 m patient hose, when the setting was on 1. 5 m. This caused a shortfall in the patient tubing filling, leaving it not purged fully with normal saline at the patient setup process. Air at the end of the hose was injected into the patient accidentally (max 4. 9 ml which is the difference between the 1. 5 m and 2. 5 m patient hose). There was no harm to the patient; the patient was under short-term observation, no medical intervention required.
 
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Brand NameULRICHINJECT CT MOTION PEDESTAL VERSION
Type of DeviceULRICHINJECT CT MOTION PEDESTAL VERSION
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM 89081
Manufacturer (Section G)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
na
ulm, 89081
GM 89081
Manufacturer Contact
christoph ulrich
buchbrunnenweg 12
na
ulm, baden-württemberg 89081
GM   89081
MDR Report Key9075247
MDR Text Key189352231
Report Number9612420-2019-00050
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K171392
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXD 8000-001
Device Catalogue NumberXD 8000-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/17/2019 Patient Sequence Number: 1
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