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

Model Number 3CX*FX25REC

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2016

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 prior to cardiopulmonary bypass, while the contents were being removed from the box, the arterial temperature connector was found to be loose inside the package. No patient involvement as this occurred out of box.

Manufacturer Narrative

The actual sample was not returned for evaluation; therefore, the complaint could not be confirmed and a definitive root cause could not be determined. A retention sample from the same product code/lot number combination was visually inspected and it was confirmed that both temperature probes, or thermistors, were securely attached to their intended ports and were not loose in the packaging. This product undergoes 100% visual inspection at several steps in the manufacturing process. It is likely that the product underwent damage during shipping and handling that caused the thermistor to break off of the port and be loose in the packaging. 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 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5695112
• MDR Text Key: 46416584
• Report Number: 1124841-2016-00230
• 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: 07/15/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2018
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: UC01
• 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: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial