MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 30 ML, IN/OUT 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 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2020 until (b)(6) 2021(197 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 blood pump is designed with a triple layer membrane separating the air chamber from blood chamber for safety reasons.The entire membrane consists of an air-side layer, a middle layer and a blood-side layer.In case of disruption in one of the triple layers, there are two more layers that will maintain the integrity of the air and blood chambers.A detailed investigation report will be provided as soon as it is available.

Event Description

Berlin heart was contacted by the clinic to report a suspected membrane defect due to decreased output in the excor blood pump of a patient supported in the lvad configuration.Berlin heart recommended a pump exchange.The affected blood pump was exchanged in the clinic by trained personnel.The exchange was performed without complications and the patient is doing well.

Manufacturer Narrative

During initial visual examination of the returned blood pump, an air cushion could be detected between the membrane layers.For further analysis, the pump was disassembled, and the membrane layers were individually examined.A leakage was detected in the air-side layer along the rolling radius of the stabilization ring.Furthermore, graphite agglomerates were found between the membranes.The middle layer and the blood-side layer of the triple layer membrane were found to be intact.The thickness of the defective membrane layer, and the one adjacent was re-measured at defined points.The thickness of the individual layers at all defined points and in the area around the leakage was found to be within specification at the time of the re-measurement.The cause of the leakage in the air-side layer was most likely an abrasion between the membrane layers.This caused increased friction at some points, which finally led to the defect in the air-side layer of the triple-layer membrane.As a result of this defect, air got in between the membrane layers and formed an air cushion, causing the reduced pump performance (incomplete filling and emptying).

• Brand Name: BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM
• Type of Device: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 11207510
• MDR Text Key: 227971967
• Report Number: 3004582654-2021-00004
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (y/n): N
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR