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

Catalog Number 701048012

Device Problem Defective Component (2292)

Patient Problem Death (1802)

Event Date 01/28/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The fact is that the patient has no direct contact with the venous probe during treatment.Requested information has not been received despite several requests.This complaint will be closed due to lack of information.The complaint will be re-opened if requested information or any new relevant information is received.No corrective action will be initialized at this time.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).It was reported by the customer (dated on (b)(6) 2018), while supporting a patient the venous probe stopped working.The perfusionist attempted to recalibrate the probe but it failed.After several attempts the clinicians decided to replace the probe with the probe from another cardiohelp.The new probe was measuring accurately the vitals.On (b)(6) 2019 there was an update, with the message that the patient is deceased.Despite repeated inquiries, there is no information about what caused the death of the patient.

• Brand Name: CARDIOHELP SYSTEM
• 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: 8344873
• MDR Text Key: 136327172
• Report Number: 8010762-2019-00036
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 701048012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/15/2019
• Event Location: Hospital
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death