MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number P15P-001

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2018 until (b)(6) 2019 (137 days).We have reviewed the production records of the excor blood pump, s/n (b)(4).This pump was produced according to our specification.Initial inspection is indicative of a suspected membrane defect.Investigation of the affected blood pump is currently ongoing and a detailed report will be submitted upon completion of the analysis.

Event Description

Berlin heart inc.Was informed by the clinic that a membrane defect was suspected in the excor blood pump of a patient supported in the lvad configuration.The clinic also noted blood and a large quantity of graphite abrasion in the air chamber.The pump was in the end diastolic position and was not ejecting.The clinic provided berlin heart inc.With images of the blood pump at the time of the incident.The images were reviewed by berlin heart inc.And an immediate exchange of the affected pump was recommended.Trained personnel at the clinic exchanged the blood pump without incidence.The patient was not affected by the exchange and is doing well.

Manufacturer Narrative

Exemption number: e2013009.Berlin heart inc.(importer number: (b)(4).Is submitting the report on behalf of berlin heart gmbh (manufacturer).On 3/10/2019, the site provided berlin heart inc.With images of the blood pump.Berlin heart inc.Ca recommended an exchange of the pump.Images showed a large amount of graphite accumulation.The clinic had provided berlin heart inc clinical affairs (ca), weekly update of patient, several videos and images of the pump during pump operation on the patient, in the time frame from (b)(6) 2019 until pump explanted on (b)(6) 2019.Based on evaluation of the videos taken by the clinic, between january 4th and february 28th; pu abrasion is to be seen in the membrane interstice.Blood could not be detected in the membrane interstice between the blood side and middle layer in any of the provided videos.Based on evaluation of videos taken between (b)(6) 2019 and (b)(6) 2019, an increase in the quantity of abrasion in the region between the blood-side and middle layer over time is clearly noticeable.Blood is visible in the membrane interstice in the images captured on (b)(6) 2019.A large quantity of abrasion (graphite) and moisture is also visible in the air chamber.Initial examination of the returned blood pump found blood deposits in between the membrane interstices, and large thrombus in the blood chamber.However, did not reveal any cushion between the membrane.Before cleaning the pump, a ct scan was taken and the images showed deposits between the layers and in the air chamber.A pressure test was performed to confirm the integrity of the blood and air chambers.No pressure drop could be detected cross the chambers, this confirmed that integrity of the blood and air chamber did not compromise.The pump was then dissembled so each membrane layer could be individually inspected.A leak was detected in the blood side layer.Multiple leaks were detected in middle layer and a leak was detected in the air-side layer.The membrane thickness of all the three membrane layers was re-measured.At all measuring points, the thickness values could be confirmed as at the time of production.The measurement in the area of leakage in the blood-side membrane showed also that the thickness profile of this layer was not homogeneous.The cause of the middle and air side membrane defects was most likely the graphite particles that formed due to an abrasion between the layers.The resulting graphite agglomerates led caused increased friction between the membranes, which finally led to the defects of the individual membranes.The leakage in the blood side layer was likely due to an inhomogeneity of the membrane thickness in the area of leakage.If the thickness distribution across a single membrane layer is not homogeneous, then there is the possibility that during pump function, the stresses in the material at the points of lower membrane thickness are higher than in the other areas of the membrane.In this case, this could lead to leakage of the membrane at these locations.

• Brand Name: EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM
• Type of Device: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 8493637
• MDR Text Key: 146100031
• Report Number: 3004582654-2019-00026
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: 04260090040157
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 03/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 MO