FDA Adverse Event Malfunction Summary report: N

CAPIOX FX OXYGENATOR

MDR report key: 10821697 · Received November 11, 2020

Report

Report Number: 9681834-2020-00230
Event Type: Malfunction
Date Received: November 11, 2020
Date of Event: October 21, 2020
Report Date: November 11, 2020
Manufacturer: TERUMO CORPORATION, ASHITAKA
Product Code: DTZ
PMA / PMN Number: K071494
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

UDI NOT REQUIRED FOR PRODUCT CODE; IMPLANTED DATE: DEVICE WAS NOT IMPLANTED; EXPLANTED DATE: DEVICE WAS NOT EXPLANTED; OCCUPATION: CLINICAL ENGINEER; PMA/510(K): K130520. THE ACTUAL DEVICE WAS NOT RETURNED, THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. AN IMAGE WAS PROVIDED BY THE USER FACILITY. REVIEW OF THE IMAGE REVEALED THAT THE LOCK ADAPTER HAD DETACHED FROM THE MALE CONNECTOR OF THE SAMPLING SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU: DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE WAS USED PRE-TREATMENT. AT THE BEGINNING OF PRIMING, THEY FOUND THAT THE LUER LOCK HAD DETACHED FROM THE SAMPLING SYSTEM. THE ACTUAL SAMPLE WAS CHANGED OUT, AND THE PROCEDURE FINISHED WITH NO FURTHER PROBLEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1287739	CAPIOX FX OXYGENATOR	OXYGENATOR, CARDIOPULMONARY BYPASS	DTZ	TERUMO CORPORATION, ASHITAKA	NA	200518

Patients

Seq	Age	Sex	Outcome	Treatment
1