MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SX OXYGENATOR W/HR (STERILE); BLOOD GAS OXYGENATOR

Model Number 3CXSX18R

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 06/23/2017

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.For this reason, terumo references evaluation conclusion.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during out of box, 16 units were short shipped.*no patient involvement as this occurred during out of box.

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 july 21, 2017.The electronic shipment of the affected product code and lot number from the tennessee distribution center to terumo (b)(4) was tracked.Several shipments were made from the distribution center; however, the total number of units that were described to be ordered and received were not all from this lot.Upon investigating the shipment of the affected product, no issues were noted.The product was not found at the distribution center, and there had been multiple verifications of the shipments accuracy prior to the product leaving the dc.It is possible that there may have been an issue in the shipping after the product left the terumo facility, or there was a miscount of product once it was received; however, neither cause could be confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SX OXYGENATOR W/HR (STERILE)
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6734279
• MDR Text Key: 80802845
• Report Number: 1124841-2017-00150
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153140
• 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,Followup
• Report Date: 08/25/2017

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: Other
• Device Expiration Date: 03/31/2019
• Device Model Number: 3CXSX18R
• Device Catalogue Number: N/A
• Device Lot Number: UE25
• Other Device ID Number: 00699753450035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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