MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number	P30P-001X01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor blood pump, s/n, (b)(4) on the patient at the time of the event was in use from (b)(6) 2021 until (b)(6) 2022 (103 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 report will be provided as soon as it is available.
Event or Problem Description
The site contacted berlin heart, inc on (b)(6) 2022 to report that a patient supported in the lvad configuration had developed hemolysis and was planning a pump change.The ldh levels were as follows: baseline 853 ((b)(6) 2021); 1362 ((b)(6) 2021); 1263 ((b)(6) 2021); 1253 ((b)(6) 2021); 2056 ((b)(6) 2021); 1429 ((b)(6) 2021); 2365 ((b)(6) 2022), 4183 ((b)(6) 2022).The high end of ldh normal for the site is 334 for this patient's age.Of note: this patient's baseline has always been elevated due to liver failure secondary to a failing fontan physiology.The site also reported that there was a soft "chirp" that was audible at the outflow valve since (b)(6) 2021 and that goes away with slight pressure over the pu valve.However, the sound returns when the pressure is released.This chirp has been unchanged since (b)(6) 2021.The pump has been filling and ejecting completely, and no dimples or graphite dust have been noted.
Additional Manufacturer Narrative
During initial visual examination of the returned blood pump, no defect could be detected.The blood pump was then tested for functional performance, where it met its required functional performance.During testing no chirping sound was detected.It was detected that the thickness profile in two of the valve leaflets varied slightly, however, still within the specification.The valves were functioning as intended, both during testing in the production and during this analysis.No vibration was observed.Previous analysis has shown that the squeaking or chirping of a blood pump valve results from a vibration of the leaflets.In this case, the reported squeaking sound at the outflow valve could not be reproduced during analysis and no vibration of the leaflets was observed.Therefore, no correlation between the pump and the increased hemolysis values of the patient could be determined.

• Brand Name: BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 13446384
• Report Number: 3004582654-2022-00011
• Device Sequence Number: 17225418
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 21 KG