MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA AF125 ARTERIAL FILTER; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date: unknown due to unknown lot number.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.Since the product code and lot number were unknown, it was not possible to investigate the manufacturing records.A search of the complaint file of the past two years found no other similar report for capiox arterial filter af125x.(b)(4).

Event Description

The user facility reported that there a split key that sealed the filter outlet on the capiox arterial filter involved; therefore, the device was unable to purge, and it closed the air inlet to the circuit.The event occurred pre-treatment.The procedure outcome was unknown.The final patient impact was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section d9, section h3, and to provide the completed investigation results according to the information, this ppr is the complaint for capiox arterial filter af125x (cx af125x or zz af125x).If the involved product was cx af125x, since the lot number was unknown, only di no.Is reported.Di no.(b)(4) if the involved product was zz af125x, udi no: n/a, as this product code is bulk product.Since the product code and the lot number were unknown, it was not possible to investigate the case.The complaint file for past two years, no other similar report of capiox arterial filter af125x was found.Since the actual product and the manufacturing record could not be investigated, it was not possible to determine the cause of occurrence.Relevant ifu reference: "do not use if the package and/or device is damaged (e.G.Cracked), or if any of the port caps are off.".

• Brand Name: AF125 ARTERIAL FILTER
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15614206
• MDR Text Key: 301818996
• Report Number: 9681834-2022-00202
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K052205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AF125X (UNKNOWN)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1