MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM; VENTRICULAR ASSIST DEVICE

Model Number P10P-001

Device Problem Output Problem (3005)

Patient Problem Sepsis (2067)

Event Date 04/07/2023

Event Type  malfunction  

Event Description

The site contacted bhi to report that care was withdrawn from the patient and the patient expired.The decision to withdraw care was based on worsening multisystem organ failure and the patient's poor prognosis.Prior to withdrawing care, the site reported that the blood pump was not filling completely and required a "high" systolic pressure to completely eject the pump.The site informed our clinical affairs team that the patient had become septic and that the patient likely had an obstruction in the inflow cannula, however there were no clots visible in the pump.The site reported in an email that when the pump was not filling completely, they switched to the hand pump "to rule out ikus malfunction" and the pump was still not filling completely but was ejecting completely.Once it was determined that the ikus was working properly, and that the pump was not filling, but was ejecting with the hand pump, care was withdrawn from the patient.

Manufacturer Narrative

The excor blood pump, (b)(6), was in use on the patient from for(b)(6) 2023 to (b)(6) 2023 ( 87 days) we have reviewed the production records of the excor blood pump s/n 2230145.This pump was produced according to our specification.Care was withdrawn from the patient on(b)(6) 2023.A detailed investigation report will be provided as soon as it is available.

Manufacturer Narrative

The excor blood pump (sn (b)(6) was returned to berlin heart gmbh on (b)(6) 2023 for evaluation.After a visual inspection, no abnormalities were found, and the triple layer membrane was in the correct position without any pillow formation.The blood pump was tested for functional performance and met all specifications with complete filling and emptying.For further evaluation, the pump was disassembled, and each individual membrane layer was examined.All three layers were intact, the graphite distribution was uniform without gaps, and the stabilizing ring was defect-free.After thorough analysis, no defects or malfunctions were found, and the blood pump met all specifications.The filling and emptying problems described by the clinic could not be attributed to any defect of the blood pump.

• Brand Name: BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM
• Type of Device: 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 grogans mill road; suite a6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 16869254
• MDR Text Key: 314564659
• Report Number: 3004582654-2023-00016
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: 04260090040102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: P10P-001
• Device Catalogue Number: P10P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 3 KG