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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 Problems Pulmonary Edema (2020); No Consequences Or Impact To Patient (2199)
Event Date 07/05/2019
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 (44 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 affected blood pump was returned to berlin heart for analysis following the exchange. The customer complaint could be confirmed. During initial visual examination of the returned blood pump, an air cushion was detected between the membrane layers. The pump was then disassembled for further testing and the membrane layers were individually tested. A leak was detected in the air-side layer, located along the rolling radius of the stabilization ring. Furthermore, a few graphite agglomerates were detected between the membrane interstices. The blood-side and middle layers of the triple layer membrane were found to be intact. The thickness of the defective membrane layer and the adjacent layer was re-measured at fixed points. At the time of investigation, the thickness of the layers at the fixed locations and also at the region of the defect was found to be within specification. The cause of the defect was most likely the graphite particles that formed due to an abrasion between the layers. This caused increased friction at points, which finally led to the defect in the air-side layer of the triple-layer membrane. As a result of this defect, air got in and formed an air cushion (pillow) in the membrane interstices, causing the reduced pump performance (incomplete filling and emptying).
 
Event Description
On (b)(6) 2019 around 2 am, incomplete ejection of the excor blood pump was noted and the patient condition was declining, febrile, hemodynamic instability and trouble breathing with decreased oxygen saturations that required intubation and mechanical ventilation. A chest x-ray was taken and pulmonary edema was noted. According to the site, an adjustment of the ikus did not improve the situation. Berlin heart was not notified until later that day after the event. The site sent berlin heart inc. A video. Upon review of the video, an air pillow was seen and berlin heart inc. Recommended an immediate exchange of the affected blood pump. Trained personnel at the site performed an exchange of the affected pump without complications and the patient was doing well again after the exchange.
 
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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 Key8827659
MDR Text Key205122857
Report Number3004582654-2019-00067
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 Other
Type of Report Initial
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model NumberP15P-001
Device Catalogue NumberP15P-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/25/2019 Patient Sequence Number: 1
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