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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 02/11/2022
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) 2021 until (b)(6) 2022 (221 days). We have reviewed the production records of the excor blood pump, s/n: (b)(6). This pump was produced according to our specification. A detailed investigation report will be provided as soon as it is available.
 
Event Description
Berlin heart inc. Was contacted by the site on 13-02-2022 to request replacement disposables for a pump change that occurred on (b)(6) 2022. The site reported that the pump was exchanged due to concern for inability to fully eject. The pump exchange was without untoward effect to the patient. When the initial contact was made no further details were available. Berlin heart inc. Contacted the site on 14-02-2022 to gather more information about the event. The site then reported that the poor ejection was noted during a routine visual inspection of the blood pump. The patient was hemodynamically stable, alert and playful. The ikus driving unit had had no alarms. The intensivist in the icu increased the systolic parameter without any improvement in ejection. The site then decided to change the blood pump. The surgical team changed the pump at the patient's bedside without event.
 
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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 Key13604473
MDR Text Key289342235
Report Number3004582654-2022-00014
Device Sequence Number1
Product Code DSQ
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 Facility
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model NumberP25P-001X01
Device Catalogue NumberP25P-001X01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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