MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM; VENTRICULAR ASSIST DEVICE

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.

Manufacturer Narrative

No abnormalities were observed upon initial examination of the returned pump.The blood pump was tested for functional performance using the driving unit settings at the time of the event reported to us by the site and repeated the functional test using different parameters defined in internal procedures.The pump performance was within specification for both the testing parameters defined by berlin heart and the clinic's settings.The pump showed complete filling and ejection.For further analysis the blood pump was disassembled, and the membrane layers were examined individually.All three membrane layers were intact and show no defect.The dispersion of graphite was uniform and gapless.The stabilization ring was not damaged.No defect nor any functional impairment was detected.The blood pump met its specification.The cause for the uniform concave dimple in the center of the membrane observed by the clinic was not able to be determined.

• Brand Name: BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM
• Type of Device: VENTRICULAR 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 Key: 14685545
• MDR Text Key: 296153752
• Report Number: 3004582654-2022-00026
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: 04260090040102
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P10P-001
• Device Catalogue Number: P10P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 4 MO
• Patient Sex: Female
• Patient Weight: 4 KG