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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE

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BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE Back to Search Results
Model Number P25P-001X01
Device Problem Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number: e2013009. Berlin heart inc. (importer number: 3008454189) is submitting the report on behalf of berlin heart gmbh (manufacturer). The excor blood pump, s/n 1(b)(4) , was in use by the patient from (b)(6) 2019 until (b)(6) 2019 (74 days). We have reviewed the production records of the excor blood pump, s/n (b)(4). This pump was produced according to our specification. The blood pump is designed with a triple layer membrane separating the air chamber from blood chamber for safety reasons. The entire membrane consists of an air-side layer, a middle layer and a blood-side layer. In case of disruption in one of the triple layers, there are two more layers that will maintain the integrity of the air and blood chambers. A detailed investigation of the returned pump is currently ongoing and a detailed report will be submitted as soon as available.
 
Event Description
We were contacted by our swiss distributor to report a reduced ejection in the right excor blood pump of a patient supported in the bivad configuration. An adjustment of the ikus stationary unit parameters did not improve the situation. The clinic provided us with a video of the blood pump at the time of the incident. Upon evaluation of the video material, berlin heart recommended an immediate exchange of the affected blood pump due to a suspected membrane defect. Trained personnel at the clinic performed an exchange of the affected pump early the next day, (b)(6) 2019. The exchange was performed without complications and the patient was doing well again after the exchange.
 
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Brand NameEXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø9 MM
Type of DeviceVENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
BERLIN HEART GMBH
wiesenweg 10
berlin, 12247
GM 12247
Manufacturer (Section G)
BERLIN HEART GMBH
wiesenweg 10
berlin, 12247
GM 12247
Manufacturer Contact
dudley rajapaksa
9391 grogan's mill road
suite a-6
the woodlands, TX 77380
2818639706
MDR Report Key8726948
MDR Text Key207178229
Report Number3004582654-2019-00061
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier04260090040119
UDI-Public04260090040119
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P160035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 06/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model NumberP25P-001X01
Device Catalogue NumberP25P-001X01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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