FDA Adverse Event Injury Summary report: N

BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM

MDR report key: 14876079 · Received June 30, 2022

Report

Report Number: 3008454189-2022-00010
Event Type: Injury
Date Received: June 30, 2022
Date of Event: June 19, 2022
Report Date: June 30, 2022
Manufacturer: BERLIN HEART GMBH
Product Code: DSQ
UDI-DI: 04260090040119
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: IL, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE EXCOR BLOOD PUMP, S/N, (B)(4) ON THE PATIENT AT THE TIME OF THE EVENT WAS IN USE FROM (B)(6) 2022 UNTIL (B)(6) 2022 (27 DAYS). 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.

Description of Event or Problem · 0

SITE CONTACTED CLINICAL AFFAIRS ON (B)(6) 2022 TO REPORT THAT THE PATIENT WAS TRANSITIONED FROM BERLIN HEART PUMP TO ECMO ON (B)(6) 2022. THE TRANSITION WAS MADE DUE TO POOR OXYGENATION AND HEMOLYSIS. SITE REPORTED THAT THE BLOOD PUMP HAD INTERMITTENT SQUEAKING NOISE SINCE IT WAS UPSIZED ON (B)(6) 2022. THE FOLLOWING LAB SERIAL VALUES WERE REPORTED: (B)(6): PLASMA FREE HEMOBLOGIN- 22 (NL <10); LDH 1718 (NL 209-463). (B)(6): PLASMA FREE HEMOGLOBIN- 17 (NL <10), LDH 2064. (B)(6): PLASMA FREE HEMOGLOBIN- 31.6 (NL <10), LDH 247. (B)(6): PLASMA FREE HEMOGLOBIN- 43.4 (NL <10). (B)(6): PLASMA FREE HEMOGLOBIN- 146.3 (NL <10). OF NOTE, THE PATIENT REQUIRED PRBC TRANSFUSION ON THE DAY PRIOR TO THE TRANSITION TO ECMO.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1016935	BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM	VENTRICULAR ASSIST DEVICE	DSQ	BERLIN HEART GMBH	P25P-001		04260090040119

Patients

Seq	Age	Sex	Outcome	Treatment
1	9 MO	Female	Other