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 No Consequences Or Impact To Patient (2199)

Event Date 03/21/2020

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2020 (5 days).We have reviewed the production records of the excor blood pump, s/n (b)(4).This pump was produced according to our specification.The blood pump is designed with a triple layer membrane separating the air chamber from blood chamber for safety reasons.The entire membrane consists of an air-side layer, a middle layer and a blood-side layer.In case of disruption in one of the triple layers, there are two more layers that will maintain the integrity of the air and blood chambers.The affected pump has not been returned to the manufacturer.A detailed investigation report will be provided as soon as it is available.

Event Description

Berlin heart was contacted by the clinic to report a suspected membrane defect of the right excor blood pump of a patient supported in the bvad configuration.The affected blood pump was exchanged in the clinic by trained personnel.The exchange was performed without complications and the patient is doing well.

Manufacturer Narrative

A correction is being made to d4, as the incorrect pump number was reported by the site.The correct number is 1920535.The excor blood pump, s /n 1920535, was in use by the patient from (b)(6) 2020 until (b)(6) 2020(5 days).We have reviewed the production records of the excor blood pump, s/n 1920535.This pump was produced according to our specification.During initial visual examination of the returned blood pump, no defect could be detected.The pump was sent for external ct scan.No anomalies of the three membrane layers could be detected via ct scan.The blood pump was then tested for functional performance, where it did reach its required functional performance.An unusual movement (star-shaped pattern) on the membrane surface could be observed, as visible in the video from the clinic.No defect was detected.The cause for the star-shaped pattern on the membrane surface could not be clearly determined.The membrane layers show no abnormalities in the thickness distribution that could lead to such a pattern.The patient was successfully supported for 5 days with the pump in question until it was preventively exchanged.

• 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, 12247 ; GM 12247
• MDR Report Key: 9883077
• MDR Text Key: 200627524
• Report Number: 3004582654-2020-00020
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: 04260090040102
• Combination Product (y/n): N
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: P10P-001
• Device Catalogue Number: P10P-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 03/22/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR