MAUDE Adverse Event Report: THORATEC CORPORATION STANDALONE PMP PEDIATRIC OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	US5087
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.
Event or Problem Description
It was reported that the after priming the amg pmp oxygenator and instituting extracorporeal membrane oxygenation (ecmo) the icu staff noticed a large amount of diluted bloody fluid in the lower chamber of the amg below the fiber bundle.The staff immediately changed the oxygenator under controlled circumstances and did not relate any issues or sequalae to the patient.The site noted that the pump speed was 3900 rotations per minute (rpm), blood flow was 1.6 liters per minute, inlet pressure was 280 millimeters of mercury (mmhg), and outlet pressure was 246 mmhg.The partial thromboplastin time (ptt) was 69.2.No issues were reported during the priming of the oxygenator.The issue occurred approximately 22 hours after initiation of support.The device was disposed.
Additional Manufacturer Narrative
Sections d4 and h4: device serial number, lot number, primary udi, expiration date and manufacture date corrected.Manufacturer's investigation conclusion: review of the submitted images confirmed an accumulation of blood in the bottom oxygenator housing consistent with a leak; however, a specific root cause for this finding could not be conclusively determined.Review of the submitted images confirmed an accumulation of red fluid/blood in the bottom housing of the oxygenator.The accumulation of fluid was beneath the fibers and within the gas pathway.The eurosets oxygenator, lot number 1045300, would reportedly not be returned for evaluation as it had been disposed of.The production documentation for the eurosets oxygenator, lot number 1045300, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.No abnormalities were documented which would cause or contribute to the reported occurrence.This device passed all required testing.Based only on the information provided by the customer and without the claimed device, eurosets was unable to identify the root cause of the problem.The production documentation for the eurosets oxygenator, lot number 1045300, was reviewed by the external manufacturer (eurosets) and showed that all tests made in the production process were compliant with the technical specifications.The eurosets amg pmp pediatric instructions for use (ifu), is currently available.Under ¿risks and side effects,¿ the ifu lists possible risks and side effects, including blood leakage caused by mechanical failure (e.G.Loss of mechanical integrity).These are potential side effects of all extracorporeal blood circulation systems.Under the list of warnings, the ifu warns that during use, a spare oxygenator must always be available and also warns that the device has to be carefully and continuously checked by qualified healthcare professionals throughout the procedure.The ifu warns to carefully check the device seal during priming and operation.If you notice leakage during priming or operation, replace the defective device following good perfusion practices.Also, under the section titled ¿set up¿¿, the ifu warns to ¿carry out a visual inspection and carefully check the device before use.Transport and/or storage conditions other than those prescribed may have caused damage to the device.¿ under the section titled ¿during bypass¿, the ifu instructs that during the entire procedure, according to good prefusion practices, monitor the integrity of the system for leaks absence.In this section, the ifu warns that ¿during cpb (cardiopulmonary bypass) check the oxygenator integrity, a small breach can also result in continuous blood loss, bacterial risk, viral infection or pyrogen reaction.A large breach can result in rapid blood loss leading to shock and death.If leakage occurs replace the oxygenator with a new one.¿ under the section titled ¿oxygenator replacement¿, this document states that a spare oxygenator must always be available during perfusion.After 6 hours of use with blood or if particular situations occur, which may lead the person responsible for perfusion to determine the safety of the patient may be compromised (insufficient oxygenator performance, leaks, abnormal blood parameters, etc.), follow the procedure outlined in the ifu for oxygenator replacement.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: STANDALONE PMP PEDIATRIC OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21392365
• Report Number: 2916596-2025-00663
• Device Sequence Number: 20981355
• Product Code: DTZ
• UDI-Device Identifier: 08052705493351
• UDI-Public: (01)08052705493351(10)1045300(17)270709
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K202206
• 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): 07/29/2025

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 Model Number: US5087
• Device Catalogue Number: US5087
• Device Lot Number: 1045300
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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: Male
• Patient Weight: 18 KG