FDA Adverse Event Malfunction Summary report: N

CAPIOX®FX

MDR report key: 24388382 · Received February 19, 2026

Report

Report Number: 9681834-2026-00025
Event Type: Malfunction
Date Received: February 19, 2026
Date of Event: January 27, 2026
Report Date: February 19, 2026
Manufacturer: TERUMO CORPORATION, ASHITAKA
Product Code: DTZ
UDI-DI: 04987350701046
PMA / PMN Number: K071494
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

. E3: OCCUPATION: DISTRIBUTOR G4: 510(K) NO.: K130520. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

Description of Event or Problem · 0

TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING PRIMING THE PUMP ONE OF THE 3-WAY CONNECTORS ON THE OXYGENATOR SAMPLING PORT WAS FOUND TO BE COMPLETELY DETACHED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
481465	CAPIOX®FX	OXYGENATOR, CARDIOPULMONARY BYPASS	DTZ	TERUMO CORPORATION, ASHITAKA	CX*FX25RW	250826	04987350701046

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown