MAUDE Adverse Event Report: ICU MEDICAL CZECH REPUBLIC A. S PORTEX TUBES BLUSELECT SUCTIONAID; BAG, RESERVOIR

Catalog Number	100/870/080CZ
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2 and b3 date of death and date of event was unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was stated that there could have been an issue with this item as the patient¿s condition got worse and then passed away.There was patient involvement and the patient died.Clinical evaluation was done.The complaint could not be confirmed because the device was not returned, and there was insufficient objective information (photos/logs/history) to determine probable cause or failure mode.Medical causality / relatedness assessment patient outcome severity: death.Causal relationship to device performance: indeterminate based on currently available information.
Additional Manufacturer Narrative
H6: codes were updated.No device was received for investigation.Therefore, the reported complaint is unable to be confirmed.If the device is received, the investigation will be re-opened for further evaluations.Based on the review of the service history and information provided from the customer we are unable to determine a probable cause as the device was not returned for evaluation.No event history log provided.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• Common Device Name: BAG, RESERVOIR
• Manufacturer (Section D): ICU MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 75301 ; EZ 75301
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25150499
• Report Number: 3012307300-2026-04863
• Device Sequence Number: 9324047
• Product Code: BTC
• UDI-Device Identifier: 15019315104862
• UDI-Public: (01)15019315104862(17)261001(10)4189344
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: Other
• Device Expiration Date: 10/01/2026
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 4189344
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2021
• 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: Death
• Patient Sex: Unknown