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

Model Number 201-90052

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 07/04/2023

Event Type  Injury  

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the patient was on the pedimag blood pump for 1 month and was 1 month old, they had struggled to have any flow for multiple days.Their flows were between 0-0.15 lpm, where the target had been 0.4 lpm.The patient was anticoagulated with bival and aspirin.Their blood volume and counts were stable.The echocardiogram showed improvement and the surgical team did not want to intervene at the time.The doctor claimed there was a clot in the cannula and tubing which was causing the low flows.There had not been any alarms for a few days.

Manufacturer Narrative

D6a - date of implant: this was previously reported incorrectly, the implant date is not applicable.Manufacturer's investigation conclusion: a direct correlation between the reported events and the pedimag blood pump could not be conclusively established through this evaluation.It was reported that the customer was having trouble getting any flow for days.Flows had been 0-0.15 liters per minute (lpm), with a target of 0.4 lpm.The patient, who was 1 month old and had been on the pedimag for 1 month, had been anticoagulated.The patient¿s volume and blood counts were stable, and an echocardiogram showed improvement.Per the physician, there was a clot in the cannulas and tubing which was causing the low flows.The physician noted that they did not want to intervene at the time.Per the account, the facility was unsure what console and monitor the patient was on so log files were unable to be retrieved.Multiple attempts for additional information were sent to the customer; however, no additional information was provided.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The instructions for use (ifu) contains the following additional warnings and cautions: ifu warning #1: the pedimag blood pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.E., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or for extracorporeal membrane oxygenation.Ifu warning #9: 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 warning #12: frequent patient and device monitoring is required.Ifu warning #17: monitor the patient¿s hemodynamics and console flow display to insure adequate blood volume for the inlet cannula position, blood pump rpm (revolutions per minute), and desired flow.Increase the pump rpm in small increments to minimize the risk of exceeding the available blood volume and causing inlet cannula obstruction, suction, outgassing, and/or cavitation.Ifu warning #18: as with all continuous flow pumps, operating at too high a speed can result in negative pressure at the inlet which can lead to collapse of the ventricle or blood vessels, inlet cannula obstruction, inspiration of air, outgassing, cavitation and increased risk of embolism.Always operate the system at the lowest speed consistent with the volume of blood available to be pumped and clinically acceptable circulatory support.Ifu warning #23: use of this pump for periods longer than durations appropriate to cardiopulmonary bypass procedures may result in pump failure, reduced pumping capacity, excessive blood trauma, degradation of blood contact materials with possibility of particles passing through the blood circuit to the patient, leaks, and increased potential for gaseous emboli.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #6: attach tubing to the pump in such a manner as to prevent kinks or restrictions that may alter flow or cause regions of stasis or turbulence.Attach in a manner that does not bend or fracture the tubing connectors or ports.Advance the tubing beyond the second barb point of the pump connectors.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a spare pedimag blood pump, back-up console, motor, and accessories available for change out.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: PEDIMAG 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
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17375242
• MDR Text Key: 319551690
• Report Number: 3003306248-2023-01961
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 201-90052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO
• Patient Sex: Female