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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 04/29/2022
Event Type  malfunction  
Event Description
Bhi was notified on (b)(6) 2022 that a rvad pump change had occurred on a patient with a bvad configuration. The site reported that the pump was changed due to incomplete "filling". Parameter adjustments did not improve the "filling. " the site also informed bhi that while adjusting the ikus settings, the driver was inadvertently paused, stopping both the rvad and lvad for approximately 5 minutes. No hand pumping was performed as the patient remained hemodynamically stable. The patient remained alert and awake for the duration of the ikus driver being paused. The driver was restarted, and the right pump continued to have decreased "filling". The site performed a pump change for the rvad. The lvad continued to function as expected with complete filling and ejection. The patient remained hemodynamically stable throughout. The pump had already been disposed of by the site when bhi was notified and cannot be retrieved.
 
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 (162 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 effected blood pump was discarded by the site, therefore unable to evaluate the reported complaint.
 
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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 Key14342241
MDR Text Key299867890
Report Number3004582654-2022-00021
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
Report Date 05/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model NumberP25P-001X01
Device Catalogue NumberP25P-001X01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2019
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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