MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø 9 MM; VENTRICULAR ASSIST DEVICE

Model Number P30P-001X01

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  malfunction  

Event Description

Berlin heart was informed by our italian distributor to report that the excor blood pump of a patient supported with excor vad system was not completely emptying.Further, the clinic reported that the membrane appeared to be touching the blood pump housing.The clinic provided berlin heart with video material of the blood pump at the time of the incident.However, the clinic exchanged the affected blood pump without prior consultation of berlin heart.The patient suffered no lasting effects.

Manufacturer Narrative

The excor blood pump, (b)(4) was in use on the patient for 35 days.We have reviewed the production records of the excor blood pump (b)(4).This pump was produced according to our specification.A detailed investigation report will be provided as soon as it is available.

Manufacturer Narrative

During initial visual examination of the returned blood pump, an air cushion was detected between membrane layers.The blood pump was then tested for functional performance, where it did not reach its required functional performance.The pump was then disassembled for further testing and the membrane layers were individually examined.Leakages were detected in the air-side and middle layer of the triple-layer membrane.All leakages were located along the rolling radius of the stabilization ring.The blood-side layer was found to be intact.Graphite agglomerates were detected between the membrane layers.The thickness of all three membrane layers was re-measured at the defined points.The thickness of the individual layers at all defined points was found to be within specification at the time of the re-measurement.In the area around the leakages, the thickness profile of the air-side layer and the middle layer was also found to be within specification at the time of the remeasurement.The cause of the leakages in the air-side layer and the middle layer was most likely graphite abrasion between the layers.This caused increased friction at points, which finally led to the defect in the air-side layer and the middle layer of the triple-layer membrane.As a result of this defect, air got in between the membrane layers and formed an air cushion in the membrane interstices, causing the reduced pump performance.When the blood-side membrane layer moving closer to the pump housing, the gap between the membrane and the pump housing is so narrow, it can be seen as recurring black flash which appears to be contact between the membranes and the housing.

• Brand Name: BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø 9 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: 16068950
• MDR Text Key: 307214071
• Report Number: 3004582654-2022-00044
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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: 10 YR
• Patient Sex: Male
• Patient Weight: 18 KG