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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM VENTRICULAR ASSIST DEVICE

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BERLIN HEART GMBH BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM VENTRICULAR ASSIST DEVICE Back to Search Results
Model Number P10P-001
Device Problem Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/24/2019
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) 2019 (172 days). We have reviewed the production records for 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 report will be provided as soon as it becomes available.
 
Event Description
We were contacted by the (b)(6) distributor to report a suspected membrane defect in the excor blood pump of a patient supported in the lvad configuration. The blood pump was exchanged by trained professionals at the clinic. The clinic provided a video and pictures of the blood pump at the time of the incident 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 NameBLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 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 Key9618148
MDR Text Key204754240
Report Number3004582654-2020-00008
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier04260090040102
UDI-Public04260090040102
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 01/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model NumberP10P-001
Device Catalogue NumberP10P-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/15/2019
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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