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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRACCO INJENEERING S.A. EMPOWER CTA +

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BRACCO INJENEERING S.A. EMPOWER CTA + Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
No information received from customer regarding the device identification, status of patient before injection, size of air bubble. No confirmation that device is involved in death. Customer is not willing to send the device back for investigation and continues to use it. A loaner was sent to hospital and had to be returned to sender. Several attempts to contact customer remained without response from the customer. Empower cta has no air detection mean. Warnings in the user manual states that: the empowercta®+ injector system must be used properly to prevent the risk of an air embolism. Always fill the syringe with the injector pointing fully upward. When the syringe has been filled to the desired volume, all the air should be purged from the syringe and coiled tubing with the injector still in the fully vertical position. Failure to do so may lead to serious injury and/or death. The overview of basic operating procedures of the same user manual states several time: remove all air from the syringes and tubing. Load position (upright) in the load position (tilted upright), the injector controller can be used to initialize syringes, fill syringes, and purge air from the syringes and tubing.
 
Event Description
On (b)(6) 2019, a healthcare professional reported to bracco injeneering that an adverse event occurred to a patient during a ct procedure with the use of empowercta. The report was forwarded to bracco drug safety on (b)(6) 2019. No medical history, concomitant medications, allergies or prior use of contrast was reported. On an unspecified date, the reporter stated that a male patient was in the emergency room prior to the injection. The patient was injected with air during an unspecified ct procedure with the use of empower cta injector. The reporter was unaware if the air was on the contrast or the saline syringe. The patient coded and passed away afterward. The date of injection, adverse event and death are unknown at this time. The reporter did not provide serial number. No further information was provided. Additional information is required.
 
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Brand NameEMPOWER CTA +
Type of DeviceEMPOWER CTA +
Manufacturer (Section D)
BRACCO INJENEERING S.A.
46 avenue sevelin
lausanne, CH-10 04
SZ CH-1004
Manufacturer (Section G)
BRACCO INJENEERING SA
46 avenue sevelin
sevelin, CH-10 004
SZ CH-10004
Manufacturer Contact
cedric boesch
46 avenue sevelin
sevelin, lausanne CH-10-004
SZ   CH-10004
MDR Report Key9140039
MDR Text Key160746145
Report Number3004753774-2019-00004
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
071378
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Report to Manufacturer09/06/2019
Date Manufacturer Received09/06/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/01/2019 Patient Sequence Number: 1
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