MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Failure to Read Input Signal (1581)

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

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Maquet (b)(4) requested the product in question for further investigation in the laboratory of the manufacturer on 07/17/2019, but the product is already discarded by the customer.Maquet cardiopulmonary is aware of a similar complaint #(b)(4) which was investigated with the following results: the product was investigated in the laboratory of the manufacturer.A visual inspection was performed on the returned hls module advanced 7.0.The venting membrane was contaminated and the yellow protective cap was not sent back.After the external cleaning, the protective cover of the pump was removed.The internal sensor was contaminated and corroded.The contacts and the board of the sensor are corroded.The flex conductor near solder joint has burst and torn on one side.Hls modules connected to the cardiohelp, to create a water cycle.The internal pressure sensor (delta p) is damaged that the sensor stops working.For information: after venting the oxygenator, the venting membrane was not closed again.Through the vent membrane the blood leaked, dripped onto the protective cover of the pump, ran under the cover where the internal pressure sensor is located.Thus the failure could be confirmed.The most probable root cause for the reported failure could be attributed to an user error.The venting membrane was not closed again after priming with the yellow protective cap, liquid can get into the interior and this could led to the corrosion of the sensor.What was clearly recognizable on the sensor.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).

Event Description

It was reported from a customer from the us that in the hls set the internal pressure sensor was not functioning.This led to a continuous sensor alarm.A number of trouble shooting attempts were made including changing the p/t cable and adjusting alarm settings without resolution.They reduced the alarm volume to its lowest level and monitor pre-membrane pressure with a separate transducer.At this point, no indication of any affects on the patient support was noted due to this issue.New information received that the customer changed out the hls set with a new on the weekend.No harm to the patient was reported.The reported failure is covered in the risk file hls set advanced 5.0 / hls set advanced 7.0 dms #(b)(4).Onetrack id: (b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 8806689
• MDR Text Key: 151597441
• Report Number: 8010762-2019-00219
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1