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

Model Number N/A

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Event Description

The user facility reported that the arterial filter lid had a bond issue.The event occurred during priming.There were no surgical delays.There was no blood loss.It was unknown if the surgery was successful.The product was changed out.The event did not cause or contribute to an injury.Additional information was received on 10 nov 2022: there were no patient issues.The arterial filter was either clamped off or replaced and setup resumed.

Manufacturer Narrative

Udi: n/a, as this product code is bulk product.Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Initial reporter occupation: unknown.The actual device was not available; therefore, the actual device will not be returned for evaluation.The manufacturing record and the shipping inspection record of the actual product found no anomaly.No other similar report was found with the product of the involved product code/lot number.Based on the investigation result, no anomaly was found in the manufacturing records.Since the actual sample could not be confirmed, the cause of occurrence could not be clarified.The instructions for use (ifu) (capiox arterial filter) of ashitaka factory has the following caution: "do not use if the package and/or device is damaged (e.G., cracked), or if any of the port caps are off." (b)(4).

• Brand Name: 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: 15954807
• MDR Text Key: 308240925
• Report Number: 9681834-2022-00246
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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: ZZ*AF125XA
• Device Lot Number: 210216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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