MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102953

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Renal Impairment (4499)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date are unknown.The investigation results will be provided in the final report.

Event Description

It was reported that on (b)(6) 2021 during index procedure the patient was transfused with 6 units red blood cells (rbcs), 2 units platelets and 2 units cryo for blood loss anemia.The patient¿s chest was left opened and packed.On (b)(6) 2021 , the patient was taken back to the operating room (or) for chest washout and closure and revision of central right ventricular assist device (rvad) support to periphera and transfused with 1 unit rbsc.On (b)(6) 2021 , the patient was transfused with an additional 2 units rbcs, 2 units fresh frozen plasma (ffp) and 1 unit of platelets.On 25feb2021, the patient was transfused with 1unit rbcs.There was also report of the patient having renal dysfunction and a history of wilm's tumor status post nephrectomy and with chronic kidney disease (ckd) stage iii with baseline creatinine (cr) 1.1-1.3.This patient underwent transplant.During the transplant centrimag device was placed (recmo).The bleeding event noted was blood loss anemia due to the surgical procedure.The patient was weaned from centrimag support on (b)(6) 2021 and discharged on (b)(6) 2021.The event reported to have resolved without sequelae on (b)(6) 2021.No additional information provided.

Event Description

Additional information reported that after the patient¿s heartmate 3 left ventricular assist device (lvad) implant, the patient quit smoking and became transplant eligible.The patient¿s procedure started in the afternoon on (b)(6) 2021 and finished early morning on (b)(6) 2021.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the reported events and the centrimag device could not be determined through this evaluation.It was reported that the patient had a bleeding event on (b)(6) 2021.During an index procedure, the patient was transfused with 6 units of packed red blood cells (prbcs), 2 units of platelets and 2 units of cryo (cryoprecipitated antihemophilic factor) for blood loss anemia.The patient¿s chest was left open and packed.The patient was taken back to the operating room (or) on (b)(6) 2021 for chest washout and closure, and revision of the central rvad (right ventricular assist device) support to peripheral; the patient was given 1 unit of prbcs.On (b)(6) 2021 , the patient was transfused an additional 2 units of prbcs, 2 units of fresh frozen plasma (ffp) and 1 unit of platelets.On (b)(6) 2021 , the patient was transfused with 1 unit of prbcs.The bleeding event reportedly resolved on (b)(6) 2021.It was reported that the patient has stage iii chronic kidney disease.A renal dysfunction event reportedly began on (b)(6) 2021 that resolved on (b)(6) 2021.The patient was weaned from centrimag support on (b)(6) 2021 and discharged on (b)(6) 2021.It was reported that the identifying information of the device could not be provided and the centrimag blood pump will not be returned for evaluation.The centrimag blood pump instructions for use (ifu) (rev.09) lists bleeding and renal dysfunction as adverse events that may be associated with the centrimag circulatory support system under ¿adverse events¿.This ifu also provides the following warnings and cautions: ifu warning #7: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warming #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 11592149
• MDR Text Key: 253843287
• Report Number: 3003306248-2021-01080
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 66