MAUDE Adverse Event Report: MAQUET GMBH CARDIOHELP-I; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Catalog Number 701048012

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Arterial bubble detection error.Error found during pm testing/service.Complaint number: (b)(4).

Manufacturer Narrative

The unit was sent to repair depot in mahwah.Work performed on 2019-05-11.Results of service order report(b)(4) : "cardio help loaner repair, complete pm, full functional, calibration and safety tests as per service manual.Unit passed all tests note: reference trackwise complaint # (b)(4)" arterial bubble detect " replaced the sensor panel with new sn# 6041.See so# 42997086 for all parts and test measurements." a probable root cause could be determined in another complaint (refer to tw#168965).Results: "momentary distortions in the serial communication between the venous bubble sensor and the sensor board due to depositions around the connector lines and micro fractures on the soldering joints could have caused the described situation." thus the failure could be confirmed.

Event Description

Complaint number: (b)(4).

• Brand Name: CARDIOHELP-I
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt
• MDR Report Key: 8649307
• MDR Text Key: 146344047
• Report Number: 8010762-2019-00150
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

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: Other
• Device Expiration Date: 10/02/2015
• Device Catalogue Number: 701048012
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 05/07/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1