MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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, during out of box a profanity was written on the packaging of the oxygenator.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 may 25, 2018.(b)(4).The molded pulp was returned and confirmed to have profanity written on it.The oxygenator in question was tracked through product and into packaging.Molded pulp product is received in plastic shrink wrap on a pallet from the supplier and remains that way until brought into packaging for production use.The recordings from the cameras in the packaging room were reviewed, and was monitored by three members of the management.There was no indications that the profanity was written at tcvs.The investigation was shifted to the supplier of the molded pulp.Their investigation determined that the issue stemmed from a disgruntled employee who is no longer with them.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7545588
• MDR Text Key: 109361659
• Report Number: 1124841-2018-00102
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: WD19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1