MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUART ARTERIAL FILTER, MODEL HBF 140; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number 00175 QUART

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

As stated by the customer: during priming, it was observed that the quart arterial filter was leaking on housing.The tubing set (incl.The quart arterial filter) has been changed with a new one before starting the operation.No patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002 (b)(4).(b)(6).The arterial filter quart has been requested for further investigation at maquet laboratory.According to the investigation report: the leakage could be confirmed.The arterial filter quart was tested under water with light air pressure (about 0.1 bar).A leakage at the adhesive connection between the housing and the cover near the "entluftungshahn" has been detected.Thus the failure could be confirmed.Root cause could be determined as bad adhesive connection.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: QUART ARTERIAL FILTER, MODEL HBF 140
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8005452
• MDR Text Key: 125140152
• Report Number: 8010762-2018-00289
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K001787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

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: 03/31/2019
• Device Model Number: 00175 QUART
• Device Catalogue Number: 700000175
• Device Lot Number: 70116051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1