MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX05RE

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional- requested, not provided.Occupation-requested, not provided.510(k) no: k130280.The actual sample was received for evaluation.Visual and magnifying inspections of the actual sampling line tube sample upon receipt revealed damage that appeared to have been cut diagonally.Magnifying and electron microscopic inspections found that the cut surface was smooth.Reproductive testing was performed using factory-retained tubing.A test sample was cut with a sharp-edged tool in one direction.The cut surface was smooth, which was similar to the state of damage on the actual sample.A test sample was cut with scissors.The cut surface was smooth, but not the same as the state of damage on the actual sample.A test sample was pinched with the bottom part of forceps.The surface of the pinched area was rough and not similar to the state of damage on the actual sample.Based on the above test results, it is likely that a sharp-edged tool came into contact with the actual sample causing the damage on it.A review of the production process of the sampling line tube was reviewed.It was confirmed that sharp-edged tools are used in tube cutting process, however, it was confirmed also that 100% leak test is performed after the sampling line assembling process.In addition, in the oxygenator assembling process after the 100% leak test, no sharp-edged tools are used.A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no findings.Ifu states: do not use if the package or device is damaged (e.G.Cracked), or any of the port caps are off.Do not use an oxygenator that leaks.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the actual sampling line tube came into contact with a sharp-edged tool, resulting in the generation of the cut on it.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that there was a cut/hole on the tubing of the sample port of capiox oxygenator.The event occurred pre-treatment.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 4103927866
• MDR Report Key: 9509644
• MDR Text Key: 219763297
• Report Number: 9681834-2019-00216
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 190125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2019
• 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