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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-001X02
Device Problem Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2019
Event Type  malfunction  
Manufacturer Narrative
The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2018 until (b)(6) 2019 (196 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. The affected blood pump has not yet been returned to us. A follow-up report with the results of a detailed investigation will be provided as soon as available. This particular model is not available in the usa. However, a similar device is available, therefore, we are reporting under the mdr regulations.
 
Event Description
We were informed by the clinic on (b)(6) 2019 of a suspected membrane defect in the excor blood pump of a patient supported in the lvad configuration. The affected blood pump was exchanged by trained professionals at the clinic on (b)(6) 2019. The exchange was performed without complications and the patient was doing well again.
 
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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 Key8777351
MDR Text Key205123026
Report Number3004582654-2019-00063
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P160035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Nurse Practitioner
Remedial Action Replace
Type of Report Initial,Followup
Report Date 07/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model NumberP25P-001X02
Device Catalogue NumberP25P-001X02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2018
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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