MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number P25P-001X02

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2018 until (b)(6) 2019 (196 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 blood pump has not yet been returned to us.A follow-up report with the results of a detailed investigation will be provided as soon as available.This particular model is not available in the usa.However, a similar device is available, therefore, we are reporting under the mdr regulations.

Event Description

We were informed by the clinic on (b)(6) 2019 of a suspected membrane defect in the excor blood pump of a patient supported in the lvad configuration.The affected blood pump was exchanged by trained professionals at the clinic on (b)(6) 2019.The exchange was performed without complications and the patient was doing well again.

Manufacturer Narrative

During the first visual examination of the returned blood pump, no abnormalities could be found.The pump was then disassembled for further testing and the membrane layers were individually tested.A small amount of graphite agglomerates were found in the membrane interstices.All three membrane layers were intact.During the production of excor blood pumps, graphite powder is applied to both surfaces of the air-side layer and middle layer, as well as to the surface of the blood-side layer which is not in contact with blood.During the pumping function when used on the patient, a small amount of graphite particles can detach from the surface of the membranes and visibly accumulate at the edge of the membrane interstices.Since the abnormality led to uncertainty for the customer, this complaint is classified as justified.

• Brand Name: EXCOR 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, 12247 ; GM 12247
• MDR Report Key: 8777351
• MDR Text Key: 205123026
• Report Number: 3004582654-2019-00063
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 07/10/2019

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: 02/28/2021
• Device Model Number: P25P-001X02
• Device Catalogue Number: P25P-001X02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 MO