MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, BLOOD TRANSFUSION

Model Number	4C8723
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clearlink system y-type blood/solution set was leaking from the area where the hand pump connects with the chamber.In this event, blood leaked through the top of the hand squeezed pump.The pressure applied to the pump sprayed blood around that side of the anesthesia/operating room area.The pump was used with both donated blood and autologous blood.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Corrected information: b1, b2, b5, d5, d10 f10, and h1.B5: the patient underwent an emergency repair of the ascending aorta with grafting, coronary artery bypass graft, and cystoscopy with suprapubic catheter placement.When the anesthesiologist went to utilize the clearlink system y-type blood/solution set in conjunction with an unknown hand pump, blood leaked from ¿the area where the pump connects with the chamber¿.When pressure was applied to the pump, blood sprayed out.Both donated and autologous blood were used.The volume of blood loss was not reported; nor was it reported if any medical intervention was initiated.No further information was available at the time of this report.
Additional Manufacturer Narrative
Correction: b1, h1 additional information: b5, h4, h6 and h11.B5: upon additional information, the leaking blood was found to be from the clearlink system y-type blood/solution set which was connected to transfused blood and not from the patient.Therefore, there was no report of patient injury or medical intervention associated with this event.H11: based on additional information received, clearlink system y-type blood/solution set was determined not to be a factor in the reported adverse event.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h11; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19955591
• Report Number: 1416980-2024-04182
• Device Sequence Number: 8962354
• Product Code: BRZ
• UDI-Device Identifier: 00085412049076
• UDI-Public: (01)00085412049076(10)R23J16048
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K993120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2024

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 Model Number: 4C8723
• Device Catalogue Number: 4C8723
• Device Lot Number: R23J16048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/15/2024; 08/27/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/15/2024; 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD TRANSFUSION; UNKNOWN HAND PUMP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White