MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 50 ML, IN/OUT Ø12 MM; VENTRICULAR ASSIST DEVICE

Model Number P50P-001

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

We have reviewed the production records of the excor blood pump s/n (b)(6).This pump was produced according to our specification.A detailed investigation report will be provided as soon as it is available.

Event Description

The site contacted berlin heart inc.To report that during the implant procedure, the pump (sn (b)(6) was placed on the patient but during the stepping process, the pump would not achieve the end diastolic (filling) position.Even after setting changes were made, and hand pumping was attempted, the pump still did not reach the end diastolic position.Clinical affairs advised to perform a pump change at this time.After changing the pump, the new pump was able to achieve full fill/eject and function as intended.

Manufacturer Narrative

We have reviewed the production records of the excor blood pump s/n (b)(6).This pump was produced according to our specifications.Berlin heart received the blood pump for evaluation on 2024-01-25.The visual inspection of the returned blood pump did not reveal any abnormalities.The blood pump was cleaned and disinfected in order to test its function.The pump performance met the specifications.The pump was completely filling and emptying, and the membrane movement showed no abnormalities.A functional test was performed to completely rule out a malfunction of the affected blood pump.Neither a defect nor a malfunction was found.All examinations revealed no abnormalities.The blood pump met its specifications.Based on surgeon's findings, it was surgical procedure error that caused the reported problem.

• Brand Name: BLOOD PUMP PU VALVES 50 ML, IN/OUT Ø12 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: 18558827
• MDR Text Key: 333457628
• Report Number: 3004582654-2024-00004
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040010
• UDI-Public: 04260090040010
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P50P-001
• Device Catalogue Number: P50P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• 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: 10 YR
• Patient Sex: Female
• Patient Weight: 33 KG