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	Contamination /Decontamination Problem (2895); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
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 circuit assesment the beside nurse noticed a small white dot rorating counterclockwise in the pump.The team continued to assess and monitor the patient.The centrimag settings were stable at 3200 rpms and 1.8 lpm.Later in the day the bedside nurse noticed an increased noise from the motor and notified the team.The on call perfusionist was called in to assess.The team decided to change to the back up motor and console.The team completed the motor and console change.The perfusion notes were perfusion services requested for pedimag drive motor change.A timeout was performed.The circuit was clamped out at 1945.Pump head was removed from drive motor sn (b)(6) / console (b)(6) and placed into new drive motor sn (b)(6) / console sn (b)(6).Pump head was observed to be in the correct position.Support was reinitiated on the new drive motor and console at 1946, back up to 3200 rpm without incident.The new backup drive motor sn (b)(6) / backup console sn (b)(6).
Event or Problem Description
The centrimag console was not exchanged.The white dot disappeared.
Additional Manufacturer Narrative
Section d5: operator of device corrected.Section h6: medical device problem code corrected.Manufacturer's investigation conclusion: neither the report of small white dot in the pump nor the report of increased noise could be confirmed as no images or product were submitted for this evaluation.A specific cause for the reported events could not be conclusively determined through this evaluation, and a direct correlation with the pedimag blood pump could not be conclusively established.The pedimag pump was not returned for evaluation.Review of the device history record (dhr) for the pedimag blood pump, lot #10148484 (l08273-lb2), revealed no deviations from manufacturing or quality assurance specifications.The pedimag blood pump instructions for use (ifu), rev c, is currently available.The section titled "inspection prior to use" states that the blood pump should be inspected prior to use for any damage or particulate matter contamination.Do not use the blood pump if damaged or if any particulate matter is found on or inside the blood pump.Contact abbott medical regarding return of any suspect blood pump.The ifu contains the following additional warnings and cautions: 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 #4: the blood pump is sterile in an unopened and undamaged unit package.Inspect device and package carefully prior to use.Do not use if the unit package or the product has been dropped, damaged or soiled.Ifu caution #15: always have a spare blood pump, back-up console, motor, and accessories available for change out.The section titled ¿pre-bypass checklist¿ warns to check the blood pump for irregular motion and noise during priming.The section titled ¿emergency back-up equipment¿ states that a sterile back-up blood pump circuit and priming accessories must be available.The current revisions of the instructions for use (ifu) and operation manual can also be found on the electronic ifu (eifu) page of the abbott website.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: 21380386
• Report Number: 3003306248-2025-00051
• Device Sequence Number: 8292628
• Product Code: QNR
• UDI-Device Identifier: 07640135140634
• UDI-Public: (01)07640135140634(10)10148484(11)240109(17)250531
• 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
• Report Date (Section B): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 201-90052
• Device Catalogue Number: 201-90052
• Device Lot Number: 10148484
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2024
• 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
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 12 KG