MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR 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 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2019 until (b)(6) 2019 (1 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.Initial visual inspection of the returned blood pump is indicative of a membrane defect.A detailed investigation report will be provided as soon as available.

Event Description

Berlin heart was contacted by the (b)(6) distributor to report the exchange of an excor blood pump of a patient supported in the lvad configuration for the incomplete filling and emptying of the affected blood pump and that the membrane was not moving to the end-positions.The 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 the initial visual examination of the returned blood pump, a cushion between membrane layers could be detected.The pump was then disassembled for further testing and the membrane layers were individually tested for leakages.A defect of the blood side layer of the blood pump was detected.The defect was located directly opposite the de-airing port and corresponded in appearance to the shape and size of the de-airing cannula's tip.The other two membrane layers were found to be intact.A mixture of blood and dried blood particles were found between the blood-side and middle layer.The thickness of the individual layers at all the fixed locations and also at the region of the defect was found to be within specification.The cause of the defect is most likely an accidental puncturing of the blood-side layer by the de-airing cannula during pump preparation.This led to a leakage in the blood-side layer.The defect led to a cushion between the middle and blood-side layer, filled with blood, which reduced the pump performance.

• Brand Name: EXCOR 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: 8944368
• MDR Text Key: 205993189
• Report Number: 3004582654-2019-00072
• 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: distributor,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: P10P-001
• Device Catalogue Number: P10P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 MO