MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number P25P-001X01

Device Problem Output Problem (3005)

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

Event Date 04/04/2022

Event Type  malfunction  

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) 2022 until (b)(6) 2022 (32 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 Description

The manufacturer was informed by the clinic about an unusual appearance of the membrane of the right excor blood pump in a patient supported with bvad configuration.The pump had delayed filling to a section of the membrane.The site suspected a membrane defect and decided to exchange the pump in question.The pump exchange was without untoward effect to the patient.

Manufacturer Narrative

During initial visual examination of the returned blood pump no abnormality was detected.The blood pump was then tested for functional performance.The pump reached its required function.The pump showed complete fill and ejection.During testing, no unusual membrane movement was observed.For further investigation, the blood pump was disassembled, and the membrane layers were examined individually.All three layers were found to be intact.The graphite was evenly distributed.The stabilization ring was intact.Neither a defect nor any malfunction of the pump was detected.The pump met its specification.

• Brand Name: BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 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 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 14106503
• MDR Text Key: 289342886
• Report Number: 3004582654-2022-00019
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: 04260090040119
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P25P-001X01
• Device Catalogue Number: P25P-001X01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• 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: 16 MO
• Patient Sex: Male