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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2022
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 (6 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 site reported that they had experienced issues with pump fill despite manipulation of the inflow cannula and parameters. The site stated that they observed a consistent concave dimple in the middle of the membrane during fill. It was decided by the site that the pump would be switched out in the event this was a membrane issue. Of note, bhi was not contacted before or during the event but was contacted after the event had occurred (b)(6) 2022). The pump change occurred without untoward effect to the patient.
 
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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, 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 Key14685545
MDR Text Key296153752
Report Number3004582654-2022-00026
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeCA
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 06/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP10P-001
Device Catalogue NumberP10P-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2021
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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