MAUDE Adverse Event Report: FRESENIUS HEMOCARE NETHERLANDS B.V. FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR; COM.TEC PL1 RED CELL / PLASMA EXCHANGE SET

Model Number N/A

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Information (3190)

Event Date 11/15/2018

Event Type  malfunction  

Event Description

Potential patient underdose.

Event Description

Potential patient underdose.Customer reported during prime, the replacement liquid flowed back to the bag and the machine alarmed "return pressure low".After check of the device and set, the tube on the replacement pump was assembled the wrong way.The tubing appeared to be assembled upside down or opposite of the specification.The customer provided a picture and video for evaluation.In the video it is visible that the com-tec generated an alarm "return pressure low".However, there is no visible deviation.Per investigation, there was no harm to the patient.This was a user inconvenience as there was a loss of set and solutions.The investigation did not identify a clear assignable cause since no deviation was visible from the picture and video received from the customer.Alarm "return pressure low" could be caused by an obstruction in the return line by kinks or by a closed clamp.

• Brand Name: FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
• Type of Device: COM.TEC PL1 RED CELL / PLASMA EXCHANGE SET
• Manufacturer (Section D): FRESENIUS HEMOCARE NETHERLANDS B.V.; runde zz 41; emmer-compascuum, drenthe NL-78 81 H; NL NL-7881 HM
• MDR Report Key: 8175055
• MDR Text Key: 131331560
• Report Number: 3002807758-2018-00004
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K060734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 9400408
• Device Lot Number: GCT 203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1