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

Model Number HBF 140-J

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2018

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

Investigation: the arterial filter quart has been returned for further investigation at maquet laboratory.Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).According to the investigation report, dated on 2019-01-25, the leakage of the quart could be confirmed.During leak test at the laboratory it has been found a leakage between the cover and the 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 (incl.Quart) 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): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8138253
• MDR Text Key: 129597824
• Report Number: 8010762-2018-00319
• 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
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: HBF 140-J
• Device Catalogue Number: 701031617
• Device Lot Number: 70122711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1