MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,30 ML IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number P30P-001X01

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the excor blood pump, s/n: (b)(4), was in use by the patient from (b)(6) 2019 until (b)(6) 2019 (4 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.A detailed investigation of the affected pump is currently ongoing and a report will be provided as soon as available.

Event Description

Berlin heart was informed by the (b)(4) distributor of a suspected fracture in the pump housing, at the stabilization ring region, of an excor blood pump of a patient supported in the lvad configuration.The clinic decided to perform an immediate exchange of the affected blood pump.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

Exemption number: e2013009.Berlin heart inc.(importer number: 3008454189) is submitting the report on behalf of berlin heart gmbh(manufacturer).The blood pump was preventively exchanged by trained personnel at the clinic due to a suspected cracked housing.The blood pump ran for 100 days.The clinic had provided berlin heart with photos of the blood pump at the time of the incident.The images show an uneven color gradient in the area where the upper shell and the air-side membrane are glued together.The affected blood pump was returned to berlin heart for analysis following the exchange.During initial visual examination of the returned blood pump, an abnormality could be confirmed in the region described by the clinic.The blood pump was then tested for functional performance where it met its required pumping specification.The pump was then disassembled and the region with the abnormality investigated in detail.An uneven color gradient was confirmed in the area where the upper shell is glued to the air-side membrane.A crack in the pump housing could not be confirmed.All three membrane layers were also found to be intact.No defect could be detected.The blood pump displayed an optical blemish.During production, the adhesion of the upper shell to the air-side membrane of the blood pump can result in such a blemish, which is not a defect nor impairs the pump function.

Manufacturer Narrative

Exemption number: e2013009.Berlin heart inc.(importer number: 3008454189) is submitting the report on behalf of berlin heart gmbh(manufacturer).A correction is being made to the sentence "the blood pump ran for 100 days." it should read "the blood pump ran for 4 days." as reported in the initial mdr.

• Brand Name: EXCOR BLOOD PUMP PU VALVES,30 ML IN/OUT Ø9 MM
• Type of Device: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 8664240
• MDR Text Key: 147489894
• Report Number: 3004582654-2019-00050
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• 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,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 YR