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 Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2020 (0 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 three layers, there are two more layers that will maintain the integrity of the air and blood chambers.The affected blood pump has not been returned to the manufacturer yet.A detailed investigation report will be provided as soon as it becomes available.

Event Description

Berlin heart inc.Was contacted by the clinic to report a suspected membrane defect of the excor blood pump supported in the lvad configuration.The clinic provided berlin heart with video material of the blood pump at the time of the event.The affected blood pump was exchanged immediately in the clinic by trained professionals without complications.The patient was not negatively affected by the event and is doing well.

Manufacturer Narrative

During the initial visual examination of the returned blood pump, blood deposits were noted between the membrane layers.The pump was then disassembled for further testing and the membrane layers were individually tested.A defect in the blood-side layer of the triple layer membrane was detected.The defect was located directly opposite the de-airing port and corresponded in appearance to the shape and size of the de-airing cannula's tip.Based on the entry and exit points in the de-airing port, the direction of the entry canal for priming could be reconstructed and coincided with the damaged location in the blood-side layer.The air-side layer and the middle layer were found to be intact.A mixture of blood and dried blood particles were found between the blood-side layer and the middle layer.The thickness of the blood-side layer and the middle layer of the returned blood pump were 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 defect is most likely an accidental puncturing of the blood-side layer of the triple layer membrane by the de-airing cannula during pump preparation.This led to a leakage in the blood-side layer.

• 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, 12247 ; GM 12247
• MDR Report Key: 9647252
• MDR Text Key: 200197907
• Report Number: 3004582654-2020-00011
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: 04260090040102
• Combination Product (y/n): N
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: P10P-001
• Device Catalogue Number: P10P-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 MO
• Patient Weight: 7