FDA Adverse Event Malfunction Summary report: N

CAPIOX®FX

MDR report key: 24714368 · Received March 30, 2026

Report

Report Number: 9681834-2026-00053
Event Type: Malfunction
Date Received: March 30, 2026
Date of Event: March 6, 2026
Report Date: March 27, 2026
Manufacturer: TERUMO CORPORATION, ASHITAKA
Product Code: DTZ
UDI-DI: 04987350701046
PMA / PMN Number: K071494
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

A2: AGE: 42. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 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. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

Description of Event or Problem · 0

TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE DEFECT WAS IDENTIFIED BEFORE APPLICATION TO THE PATIENT. CLOTTING WAS OBSERVED IN THE RESERVOIR FILTER DESPITE ADEQUATE HEPARINIZATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE PROCEDURE WAS DELAYED DUE TO A PRODUCT ISSUE IDENTIFIED PRIOR TO PATIENT USE. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
607156	CAPIOX®FX	OXYGENATOR, CARDIOPULMONARY BYPASS	DTZ	TERUMO CORPORATION, ASHITAKA	CX*FX25RW	250704	04987350701046

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown