MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,60 ML IN/OUT Ø12 MM; VENTRICULAR ASSIST DEVICE

Model Number	P60P-001X01
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on information provided by the site, initially it was determined that this complaint was not reportable, but upon receiving the affected blood pump on 2019-07-18 and resulting investigation completed on 2019-08-01determined that the event is reportable.The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2019 until (b)(6) 2019(170 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.The affected blood pump was returned to berlin heart for analysis following the exchange.The customer complaint was confirmed.During initial visual examination of the returned blood pump, the particles in the air chamber could not be seen.However, a reddish-brown fluid deposit was visible in the membrane interstices.The pump was then disassembled for further testing and the membrane layers were individually tested.A leakage was detected in the blood-side layer and several in the middle layer.The leak on the blood-side layer was located at the edge region of the membrane.The leaks in the middle layer were located at the edge and close to the center of the membrane.The air-side layer was found to be intact.Coagulated blood residues were detected between the membrane layers.After disassembling the air chamber, the graphite particles confirmed in the video could be seen again.The thickness of all three membrane layers were re-measured at fixed points.At the time of investigation, the thickness of the layers at the fixed locations was found to be within specification.The measurement in the region of the defects also showed that the thickness profile of the middle layer was not homogeneous.The cause of the leaks in the middle layer was an inhomogeneity in the membrane thickness of this layer.If the thickness distribution across a 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.In this case, the middle layer showed extensive damage, which then led to an asymmetrical load on the adjacent air-side and blood-side layers.As a consequence, a leakage resulted in the blood-side layer as well.
Event or Problem Description
We were informed about increased graphite deposits in the air chamber of the left excor blood pump of a patient supported in the bivad configuration.Upon evaluation of videos from the clinic, berlin heart recommended an exchange of the affected blood pump.Trained personnel at the clinic performed an exchange of the affected blood pump on (b)(6) 2019.The exchange was performed without complications and the patient was doing well again after the exchange.

• Brand Name: EXCOR BLOOD PUMP PU VALVES,60 ML IN/OUT Ø12 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 8888363
• Report Number: 3004582654-2019-00070
• Device Sequence Number: 2683369
• Product Code: DSQ
• UDI-Device Identifier: 04260090040027
• UDI-Public: 04260090040027
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: P60P-001X01
• Device Catalogue Number: P60P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR