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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR APEX CANNULA FOR CHILDREN VENTRICULAR ASSIST DEVICE

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BERLIN HEART GMBH EXCOR APEX CANNULA FOR CHILDREN VENTRICULAR ASSIST DEVICE Back to Search Results
Model Number C22A-004
Device Problem Fracture (1260)
Patient Problem Air Embolism (1697)
Event Date 12/19/2021
Event Type  Death  
Manufacturer Narrative
The excor cannula lot 00060726, was in use by the patient from (b)(6) 2018 until (b)(6) 2021 (1108 days). We have reviewed the production records of the excor cannula lot 00060726. This cannula was produced according to our specification. The investigation is still ongoing and a detailed investigation report will be provided as soon as it is available.
 
Event Description
We were informed by the distributor on (b)(6) 2021 about a breach in the inflow cannula of a patient supported with the excor pediatric in the lvad configuration. The clinic reported the breach was found in the cannula in the area of the blood pump connector. Air was introduced into the cannula at the site of the breach resulting in an air embolism to the patient. The patient, who had been supported with the excor pediatric for 1108 days died as a result of this event.
 
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Brand NameEXCOR APEX CANNULA FOR CHILDREN
Type of DeviceVENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
BERLIN HEART GMBH
wiesenweg 10
berlin, deu 12247
GM 12247
Manufacturer (Section G)
BERLIN HEART GMBH
wiesenweg 10
berlin, deu 12247
GM 12247
Manufacturer Contact
dudley rajapaksa
9391 grogan's mill road
suite a-6
the woodlands, TX 77380
2818639706
MDR Report Key13236051
MDR Text Key283670854
Report Number3004582654-2022-00006
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P160035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberC22A-004
Device Catalogue NumberC22A-004
Device Lot Number00060726
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/12/2022 Patient Sequence Number: 1
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