MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PEDIMAG BLOOD PUMP; BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE

Model Number	201-90052
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Codes	Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that during physical therapy/occupational therapy, the patients nurse noticed a rattling noise from the pedimag motor.Code was activated.Multiple attempts were made to adjust the pump in the motor housing.This was unsuccessful.The pump was switched to the backup motor and console.The motor and console were removed from service and sent to the biomedical engineer.
Event or Problem Description
It was communicated on (b)(6) 2024 that an extracorporeal membrane oxygenation (ecmo) code was activated for extra staffing support whenever ventricular assist devices (vads) fail as part of the hospital's emergency response.The patient experienced hemolysis occurred that had since resolved.There were no alarms associated with the event.The noise resolved with motor and console exchange.The products were returned for evaluation.The patient remained stable and was continuing on vad support until heart transplant.
Additional Manufacturer Narrative
B5 narrative info.H6 - adverse event problem code.H10 - related report numbers.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Correction - section d4 (udi number).Section d4: device lot number was not provided.The primary udi number in d4 is reflective of all available information.Manufacturer's investigation conclusion: a direct correlation between the pedimag blood pump, lot number l08129-lb3, and the reported hemolysis could not be conclusively established through this evaluation.The pedimag blood pump was not available for evaluation.The relevant sections of the device history records for pedimag blood pump, lot number l08129-lb3, were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pedimag blood pump instructions for use (ifu) is currently available.This ifu also provides the following warnings and cautions: ifu warning #3: list hemolysis as a possible side effect.Ifu warning #9: it is intended that systemic anticoagulation be utilized while the 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 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: PEDIMAG BLOOD PUMP
• Common Device Name: BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20666093
• Report Number: 2916596-2024-07310
• Device Sequence Number: 7211333
• Product Code: QNR
• UDI-Device Identifier: 07640135140634
• UDI-Public: (01)07640135140634(10)(17)250328
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2025
• Device Model Number: 201-90052
• Device Catalogue Number: 201-90052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/06/2024; 01/29/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/17/2024; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2022
• 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: Required Intervention
• Patient Age: 13 MO
• Patient Sex: Female
• Patient Weight: 10 KG