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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE

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BERLIN HEART GMBH 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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2022
Event Type  malfunction  
Manufacturer Narrative
The excor blood pump, s/n: (b)(4), on the patient at the time of the event was in use from (b)(6) 2022 until (b)(6) 2022 (32 days). We have reviewed the production records of the excor blood pump, s/n: (b)(4). This pump was produced according to our specification. A detailed investigation report will be provided as soon as it is available.
 
Event Description
The manufacturer was informed by the clinic about an unusual appearance of the membrane of the right excor blood pump in a patient supported with bvad configuration. The pump had delayed filling to a section of the membrane. The site suspected a membrane defect and decided to exchange the pump in question. The pump exchange was without untoward effect to the patient.
 
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Brand NameBLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM
Type of DeviceVENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
BERLIN HEART GMBH
wiesenweg 10
berlin, deu 12247
GM 12247
Manufacturer (Section G)
BERLIN HEART GMBH
wiesenweg 10
berlin, deu 12247
GM 12247
Manufacturer Contact
dudley rajapaksa
9391 grogan's mill road
suite a-6
the woodlands, TX 77380
2818639706
MDR Report Key14106503
MDR Text Key289342886
Report Number3004582654-2022-00019
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,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP25P-001X01
Device Catalogue NumberP25P-001X01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2021
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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