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U.S. Department of Health and Human Services

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

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BERLIN HEART GMBH 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 01/04/2020
Event Type  malfunction  
Manufacturer Narrative
The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2019 until (b)(6) til 2020 (197 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 on of the three 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 it becomes available.
 
Event Description
Berlin heart was contacted by the japanese distributor to report a suspected membrane defect of the excor blood pump of a patient supported in lvad configuration. The distributor provided berlin heart with pictures and video material of the blood pump at the time of the incident. The affected blood pump was exchanged in the clinic by trained professionals without complications. The patient was not negatively affected by the incident and is doing well.
 
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Brand NameBLOOD 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 Key9634927
MDR Text Key186727478
Report Number3004582654-2020-00009
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier04260090040157
UDI-Public04260090040157
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 distributor,foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberP15P-001
Device Catalogue NumberP15P-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/19/2017
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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