MAUDE Adverse Event Report: HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.

Event Description

Product arrived with the peel pack portion of the hls set that had been compromised (not sealed) during shipping.(b)(4).

Manufacturer Narrative

3 attempts were performed by the ssu usa (2020-10-01 by phone, 2020-10-05 by phone, 2020-10-12 by visit) to obtain the product back for manufacturers laboratory investigation.The attempts were unsuccessful.Therefore a laboratory investigation could not be performed.By the provided picture could be determined that the tyvek cover of the hls tray was most probable compromised by a cut.The cut could have been occurred when the outer box of the hls set packaging was opened with an cutter.By the performed device history record review of our r&d packaging engineer it was confirmed that the cut protection insert was included into the hls outer box.Beside of this a symbol is printed on the outer box cartons of the hls sets, that shows that no blade knifes should be used to open the box.Thus the reported failure could be confirmed but was most probable not caused by a packaging malfunction.The most probable cause of the reported failure could be that a blade knife was used with heavy pressure to open the carton box, which also compromised the cut protection insert and the sterile layer of the tyvek cover.When the event occurred, the product was not used for patient treatment.The product was directly involved in the event.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id:(b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• MDR Report Key: 10763564
• MDR Text Key: 213906704
• Report Number: 8010762-2020-00364
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70137762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1