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

Model Number #HL 20, 4-PUMPS CONSOLE BASE

Device Problems Increased Pump Speed (1501); Failure to Pump (1502)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch will be submitted after new information has been received.(b)(4).

Event Description

It was stated that during the ongoing surgery the error messages "run away" and "safety-s" occured on arterial pump.No indication of actual or potential for harm or death was stated.No further information provided.Complaint# (b)(4).

Event Description

Reference number: (b)(4).

Manufacturer Narrative

The defective device was removed from clinical use and sent to ssu warehouse for investigation.Getinge ssu replaced the device at customers site with a hlm device.The defective device was repaired by the ssu, but customer will keep the new hlm device.The replaced parts were not investigated yet by the ssu as the device was already replaced, therefore no most probable root cause could be determined.We will reopen the complaint when the parts were investigated and if significant information becomes available.The reported failure " run away and safety-s error" could not be confirmed.The occurrence rate is below the acceptance rate, thus no remedial action required.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Manufacturer Narrative

The getinge field service technician (fst) was sent out to perform service works.According to the service report following works have been done: the fst checked and replaced optical tacho pcba (hl20 rpm) (material# 701020599, serial# (b)(6)) in pumps serial number (b)(6).The control pcba safety system (hl20) (material# 701007756, serial# (b)(6)) was also replaced in pump serial number (b)(6).Furthermore, the fst cleaned all carbon brushes in all pumps and verified voltages on all test points which was ok.After repair unit has been tested for one day and found working in satisfactory condition.The defective part have been requested but feedback is pending.A supplemental medwatch will be submitted after new information has been received.

Event Description

Complaint# (b)(4).

• Brand Name: HEART-LUNG BYPASS SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8636341
• MDR Text Key: 145939743
• Report Number: 8010762-2019-00133
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: #HL 20, 4-PUMPS CONSOLE BASE
• Device Catalogue Number: 701043266
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1