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

Model Number HBF 140-J

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2018

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 incoming goods inspection leakage at the arterial filter has been detected.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).Investigation: the arterial filter quart has been returned for further investigation at maquet laboratory.According to investigation report, dated on 2019-01-28, the leakage of the quart could be confirmed.During leak test it has been found a leakage between cover and housing, near the bypass-tap (white) of the quart.Thus the failure could be confirmed.Most probable root cause could be determined as bad welding between the cover and the housing.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.Correction: according to complaint report, dated on (b)(6) 2018, the issue has been detected prior to use.No patient involvement.The set was replaced before patient treatment.Corrective action: since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.

Event Description

Ref.: (b)(4).

• Brand Name: QUART ARTERIAL FILTER, MODEL HBF 140
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• MDR Report Key: 8138245
• MDR Text Key: 129597717
• Report Number: 8010762-2018-00320
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

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: 10/31/2018
• Device Model Number: HBF 140-J
• Device Catalogue Number: 701031617
• Device Lot Number: 70114652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 11/19/2018
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1