MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. (b)(4).

Event Description

The user facility reported to terumo cardiovascular that the tape that closes the box needs to extend to the pull tab in order to open the box properly. The tape does not connect with the pull tab so they have to manually open the boxes. They are afraid that if they use a sharp instrument, they will compromise the sterility of the product inside the box. This event occurred during a non clinical activity; therefore, there was no patient involvement.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations - and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on june 13, 2016. (b)(4). The actual sample was not returned for evaluation; therefore, the complaint was not confirmed. There was no specific lot identified to be affected by the reported issue; therefore, a review of the device history records could not be performed. The packaging process was reviewed and it was confirmed that the taping machine used for the outer boxes automatically meters out the correct length of tape; however, it must be properly adjusted in order to be correct. The length of tape on the box is not a functional issue, as it only affects how the packaging must be opened. All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21911
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5720002
• MDR Text Key: 47215019
• Report Number: 1124841-2016-00240
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00699753450820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/14/2016
• 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