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 02/11/2022

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) 2021 until (b)(6) 2022 (221 days).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

Berlin heart inc.Was contacted by the site on 13-02-2022 to request replacement disposables for a pump change that occurred on (b)(6) 2022.The site reported that the pump was exchanged due to concern for inability to fully eject.The pump exchange was without untoward effect to the patient.When the initial contact was made no further details were available.Berlin heart inc.Contacted the site on 14-02-2022 to gather more information about the event.The site then reported that the poor ejection was noted during a routine visual inspection of the blood pump.The patient was hemodynamically stable, alert and playful.The ikus driving unit had had no alarms.The intensivist in the icu increased the systolic parameter without any improvement in ejection.The site then decided to change the blood pump.The surgical team changed the pump at the patient's bedside without event.

Manufacturer Narrative

During initial visual examination of the returned blood pump, an air cushion could be detected between the membrane layers.The blood pump was then tested for functional performance where it did not reach its required functional specification, confirming the customer's complaint.For further analysis, the pump was disassembled, and the membrane layers were individually examined.A leakage was detected in the air-side layer along the rolling radius of the stabilization ring.Furthermore, graphite abrasion was found between the membranes.The middle layer and the blood-side layer of the triple layer membrane were found to be intact.The thickness of the defective membrane layer, and the one adjacent was re-measured at defined points.The thickness of the individual layers at all defined points and in the area around the leakage was found to be within specification at the time of the remeasurement.The cause of the leakage in the air-side layer was most likely a graphite abrasion between the membrane layers.This caused increased friction at some points, which finally led to the defect in the air-side layer of the triple-layer membrane.As a result of this defect, air got in between the membrane layers and formed an air cushion, causing the reduced pump performance (incomplete filling and emptying).

• 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: 13604473
• MDR Text Key: 289342235
• Report Number: 3004582654-2022-00014
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: 04260090040119
• 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: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: P25P-001X01
• Device Catalogue Number: P25P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 17 KG