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

Model Number	P60P-001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number: e2013009.Berlin heart inc.(importer number: (b)(4)) is submitting the report on behalf of berlin heart gmbh(manufacturer).The excor blood pump, s/n (b)(4), was in use by the patient from 2017-08-07 until 2018-10-24(443 days).We have reviewed the production records of the excor blood pump, s/n (b)(4).This pump was produced according to our specification.A detailed investigation of the returned pump is currently ongoing and a report will be provided as soon as available.
Event or Problem Description
We were contacted by the clinic who reported that the left excor blood pump of a patient supported in the bvad configuration appeared to have a leak at the junction between the blood pump and the driving tube, at the connector region.The affected blood pump was exchanged by trained professionals at the clinic in the early morning hours of (b)(6) 2018.The exchange was performed without complications and the patient is doing well.
Additional Manufacturer Narrative
Exemption number: e2013009.Berlin heart inc.(importer number: 3008454189) is submitting the report on behalf of berlin heart gmbh(manufacturer).During initial visual examination of the returned blood pump, a breakage of the pump housing at the region of the connector stub, which connects the pump to the driving tube was confirmed.This led to a minimal leakage of air.The blood pump could not be tested for functional performance due to the air leak.The appearance of the breakage in the pump housing is indicative of a fatigue failure, the exact cause for which is unknown.The affected blood pump was used on the patient for 443 days in spite of reminding the user to change the pump after 365 days.The duration of use was, therefore, well above the maximum prescribed duration of 365 days as per the instructions for use.If a blood pump has been in use for 330 days, users of the blood pumps are sent a reminder by the manufacturer that the maximum operating time of the excor blood pump prescribed by the ifu is 365 days.Additionally, during the course of the detailed investigation of the returned blood pump, the middle layer of the triple layer membrane was found to be defective.The integrity of the air and blood chambers continued to be maintained.The cause of the defects in the middle layer was most likely due to the graphite particles that formed due to the abrasion between the membrane layers.This most likely caused increased friction at certain points, leading to the middle layer defect.

• 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: 8073976
• Report Number: 3004582654-2018-00058
• Device Sequence Number: 244527
• Product Code: DSQ
• UDI-Device Identifier: 04260090040027
• UDI-Public: 04260090040027
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 09/30/2017
• Device Model Number: P60P-001
• Device Catalogue Number: P60P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR