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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE

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BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE Back to Search Results
Model Number P15P-001
Device Problem Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2019 (49 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. Initial visual inspection of the returned blood pump is indicative of a membrane defect. A detailed investigation report will be provided as soon as available.
 
Event Description
Berlin heart inc. Was informed by the clinic about an exchange of the left excor blood pump of a patient supported in the bvad configuration. The clinic suspected reduced ejection in the affected blood pump. An adjustment of the ikus stationary driving unit parameters had not improved the situation and the clinic decided to exchange the affected blood pump. The exchange was performed without complications by trained personnel at the clinic. The patient was not affected by the incident and is doing well.
 
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Brand NameEXCOR BLOOD PUMP PU VALVES,15 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 Key8800520
MDR Text Key200420192
Report Number3004582654-2019-00065
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier04260090040157
UDI-Public04260090040157
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 07/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model NumberP15P-001
Device Catalogue NumberP15P-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2019
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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