MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HEART-LUNG BYPASS SYSTEM, HL20; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number COUNTRY KIT, HL 20

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).The field service technician (fst) was onsite and following was found: according to service report# (b)(4); dated on 2018-05-23 the fst was not able to duplicate the issue.The fst replaced the control pcba (hl20 rpm) (material# 701007754, old board serial# (b)(4), new board serial# (b)(4)) due to preventive measure.All connectors and odu's checked again.Functional test performed and rpm works properly.Thus the failure could not be confirmed.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.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

It was reported that the rpm switched off during operation and produced the continuous beep.The rpm display showed \"err\".On the hl20 sn (b)(4).Rpm was art pump, patient was on it.After restarting the pump, the operation could be finished without any problems.No known patient harm.(b)(4).

• Brand Name: HEART-LUNG BYPASS SYSTEM, HL20
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 7586891
• MDR Text Key: 111157348
• Report Number: 8010762-2018-00205
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COUNTRY KIT, HL 20
• Device Catalogue Number: 701028600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention