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 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump,s/n (b)(4), was in use by the patient from (b)(6) 2020 until (b)(6) 2020 (46 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 pump was returned to the manufacturer on 3/13/2020.A detailed investigation report will be provided as soon as it is available.

Event Description

Berlin heart inc.Was informed by the clinic about the exchange of the left excor blood pump of a patient supported in the bvad configuration.The pump was exchanged due to incompletely filling.The site stated that an adjustment of the ikus stationary driving unit parameters did not improve the situation.A membrane defect was suspected and the affected blood pump was exchanged by trained professionals at the clinic.The exchange was performed without complications and the patient is doing well.

Manufacturer Narrative

During initial visual examination of the returned blood pump, no defect could be detected.No graphite was seen.The blood pump was then tested for functional performance, where it did reach its required functional performance.The blood pump was fully filling and emptying.The pump was then disassembled for further testing and the membrane layers were individually examined.All three membrane layers were found to be intact.No membrane defect was found.The cause of the incomplete filling the clinic described 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, 12247 ; GM 12247
• MDR Report Key: 9841652
• MDR Text Key: 204048328
• Report Number: 3004582654-2020-00017
• 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: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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: 05/31/2022
• Device Model Number: P10P-001
• Device Catalogue Number: P10P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Weight: 5