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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 50 ML, IN/OUT Ø12 MM VENTRICULAR ASSIST DEVICE

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BERLIN HEART GMBH BLOOD PUMP PU VALVES 50 ML, IN/OUT Ø12 MM VENTRICULAR ASSIST DEVICE Back to Search Results
Model Number P50P-001
Device Problem Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
Event Type  malfunction  
Manufacturer Narrative
We have reviewed the production records of the excor blood pump, s/n (b)(4). This pump was produced according to our specification. The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2019 (160 days). 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 report will be provided as soon as available pending return of the affected blood pump.
 
Event Description
Berlin heart (b)(4) were informed by the clinic about a suspected membrane defect of the right excor blood pump of a patient supported in bvad configuration. The affected blood pump was exchanged by trained personnel at the clinic without complications and the patient is doing well.
 
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Brand NameBLOOD PUMP PU VALVES 50 ML, IN/OUT Ø12 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 grogans mill road
suite a-6
the woodlands, TX 77380
2818639706
MDR Report Key9603844
MDR Text Key200866819
Report Number3004582654-2020-00007
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier04260090040010
UDI-Public04260090040010
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P160035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberP50P-001
Device Catalogue NumberP50P-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2018
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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