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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 05/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2018 until (b)(6) 2019 (174 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 is indicative of an air-side membrane defect. A detailed investigation report will be provided as soon as available.
 
Event Description
Berlin heart was informed by the (b)(4) distributor of the replacement of an excor blood pump of a patient supported in the lvad configuration. The clinic noted an unusual membrane movement and a visible air cushion between the membrane layers. The clinic suspected a membrane defect and decided to perform an exchange of the affected blood pump. The blood pump was exchanged by trained professionals at the clinic. The exchange was performed without complications and the patient is doing well.
 
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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 Key8711874
MDR Text Key148441839
Report Number3004582654-2019-00059
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier04260090040119
UDI-Public04260090040119
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 06/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model NumberP25P-001X01
Device Catalogue NumberP25P-001X01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2017
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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