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

Model Number	P30P-001X01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump, (b)(6), was in use on the patient from (b)(6) 2023 until (b)(6) 2023.We have reviewed the production records of the excor blood pump, s/n (b)(6).T his pump was produced according to our specification.The site did not report ldh values until (b)(6) 2023.After reviewing these values, it was determined that this event should be reportable since ldh levels are more than 2.5 times the upper acceptable range for this patient.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
The site contacted bhi clinical affairs on (b)(6) 2023 to report a "squeaking pump".According to the site, the squeaking sound was intermittent, and resolved when light pressure was applied to the outflow valve.The pump continues to function as expected, with complete filling and ejection.A video of the pump was provided by the site, which demonstrated the complaint.No current hemolysis lab values were available but were requested by bhi.Since the site did not report any adverse impact to patient associated purported abnormality at the time of the event, it was determined as not reportable.The site contacted bhi clinical affairs again on (b)(6) 2023, to report an increase in the "squeaking noise" of the pump.They also stated it sounded like the pump had an "increase in friction." photos and videos of the pump were obtained.The site also reported that the patient had an increased ldh (but did not report an exact value), and after reviewing the photos & videos provided by the site, berlin heart recommended pump change.The site changed the pump on (b)(6) 2023.However, site did not report ldh values until (b)(6) 2023.After reviewing these values, it was determined that this event should be reportable since ldh levels are more than 2.5 times the upper acceptable range for this patient.

• Brand Name: BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• MDR Report Key: 16883684
• Report Number: 3008454189-2023-00007
• Device Sequence Number: 5829958
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2023
• Report Date (Section F): 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2023
• Device Age: 43 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 MO
• Patient Sex: Female
• Patient Weight: 10 KG
• Date Report Sent to FDA: 05/07/2023