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	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump, s/n (b)(4) on the patient at the time of the event was in use (b)(6).We have reviewed the production records of the excor blood pump, s/n (b)(4).This pump was produced according to our specification.A detailed investigation report will be provided as soon as it is available.As of (b)(6) 2022 the patient's ldh level was 4000, showing no decrease after changing the pump in use on (b)(6) 2022.
Event or Problem Description
Site contacted berlin heart ca on (b)(6) 2022 to report that the patient had elevated ldh levels, and the pump was exchanged due to concerns for hemolysis.The following lab values were reported: (b)(6): plasma free hemoglobin - 235.(b)(6): ldh - 1383.(b)(6): ldh - 3900.Normal values for the site ldh -1383.Pump maintained completed fill and ejection.Site reported there were neither acoustic nor visual abnormalities associated with the blood pump.In addition, there are no deposits reported.
Additional Manufacturer Narrative
As of 2022-12-09, the affected excor blood pump, s/n (b)(6) has not been returned to berlin heart despite the initial intent of the site to return the product for investigation.After numerous contact attempts, berlin heart assumes the blood pump in question will not be returned for investigation.As of (b)(6) 2022, the patient's ldh level has returned to baseline.

• 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
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 15498585
• Report Number: 3004582654-2022-00037
• Device Sequence Number: 5856509
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 09/30/2024
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 MO
• Patient Sex: Male
• Patient Weight: 9 KG