MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 50 ML, IN/OUT Ø12 MM; VENTRICULAR ASSIST DEVICE

Model Number P50P-001

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

We have reviewed the production records of the excor blood pump, s/n (b)(4).This pump was produced according to our specification.The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2019 (160 days).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 available pending return of the affected blood pump.

Event Description

Berlin heart (b)(4) were informed by the clinic about a suspected membrane defect of the right excor blood pump of a patient supported in bvad configuration.The affected blood pump was exchanged by trained personnel at the clinic without complications and the patient is doing well.

Manufacturer Narrative

During initial visual inspection of the returned blood pump, the membrane layers did not lie smoothly on top of each another, confirming the customer's complaint.During inspection, increased abrasion in between the membrane layers could be identified.The membrane layers were then individually tested.The blood-side layer of the triple layer membrane showed abrasion of graphite in the edge region along the stabilization ring.No leakage was found in the blood-side layer.In the middle layer, a tear like defect was found.The membrane layer was torn in the edge region along the stabilization ring for more than half the membrane circumference.The blood-side layer and the air-side layer were found to be intact.The thickness of all three membrane layers was re-measured at 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.Additionally the thickness of the middle layer was re-measured at 4 extra locations close to the tear like defect, the thickness here was found to be within specification as well.Based on shape of the tear, the membrane layer may have torn in one small area first and then the tear spread out gradually with the pumping function.The cause of the initial failure was most likely graphite abrasion between the membrane layers.This caused increased friction at points, which finally led to a defect in the middle layer of the triple layer membrane.The tear was then noticed by the clinic as the membrane layers not lying smoothly on each other.

Manufacturer Narrative

Under d4 serial number, the incorrect serial number was listed as (b)(6).The correct serial number as reported in h10 is (b)(6).

• Brand Name: BLOOD PUMP PU VALVES 50 ML, IN/OUT Ø12 MM
• Type of Device: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 9603844
• MDR Text Key: 200866819
• Report Number: 3004582654-2020-00007
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040010
• UDI-Public: 04260090040010
• Combination Product (y/n): N
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: P50P-001
• Device Catalogue Number: P50P-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 12/18/2019; 12/18/2019
• Supplement Dates FDA Received: 01/22/2020; 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR