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

Model Number 201-90052

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  Injury  

Event Description

It was reported that blood leakage was visualized on the blood pump.The pump was exchanged, and the patient tolerated well with no adverse events noted.The leak was on the outflow pump head.There had been one pump exchange previously after approximately 3 weeks of support of the right ventricular assist device (rvad) pump.

Manufacturer Narrative

The previous exchange is reported in manufacturer report number:3003306248-2021-07037.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Section d6a: implant date was inadvertently included in the initial report and is not applicable for this device.Manufacturer investigation conclusion the reported blood leak from the outlet housing was confirmed from the evaluation of the returned pedimag blood pump.The pedimag blood pump, lot number l06049-lb7, was returned with segments of tubing connected to both the inlet and outlet ports secured with zip ties.The inlet port revealed no evidence of cracking or other damage.Visual inspection of the outlet port revealed no obvious signs of cracking; however, there appeared to be dried blood within the seal between the interior of the outlet and outside of the blood contacting surface.Examination of the pump housing revealed no depositions or thrombus formations.Examination of the impeller portion of the pump rotor revealed no evidence of depositions or thrombus formations.The rotor blades revealed no evidence of abrasion or damage.Examination of the rotor base and rotor well revealed no evidence of depositions or thrombus formations.The rotor base showed no evidence of abrasion or other damage.The rotor well revealed no evidence of abnormal scratching or other damage.There was no evidence of separation or slippage between the rotor magnet and rotor body.Following cleaning, visual inspection of the blood pump revealed dried blood residue within the seal between the outlet port and the exterior of the pump.During preparation for hydraulic qualification (hq) testing, the pedimag was being handled to insert into a test motor and the pump split in half along one of its sealing points.Visual and microscopic inspection of the pump sealing revealed dried blood residue within the grooves of the seal and outside of the blood contacting areas.A manufacturing analysis was initiated to investigate the root cause of this issue.During the root cause investigation for the manufacturing analysis, two potential root causes were identified and retained.The issue was not introduced by customer handling but rather by a manufacturing related issue.The pedimag blood pump ifu, rev.04 contains the following warnings and cautions: ifu warning #12: frequent patient and device monitoring is recommended.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 #15: always have a spare pedimag blood pump, back-up console, motor and accessories available for change-out.The section titled blood pump setup and operation warns the user that if leaks or other anomalies are found on the centrimag vad, remove the blood pump and replace with a new, sterile blood pump.The ifu also contains a section titled emergency blood pump replacement.The device history record for the pedimag blood pump, lot number l06049-lb7, was reviewed and showed no deviations from manufacturing or quality assurance specifications.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: 12980377
• MDR Text Key: 283150878
• Report Number: 3003306248-2021-07027
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140634
• UDI-Public: 07640135140634
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 201-90052
• Device Catalogue Number: 201-90052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 15 KG