MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS-7050

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

It was reported that initiation of vv (veno venous) support was at 1513 (b)(6) 2021.At 1830, part (arterial pressure) was jumping around from 33 to 220 mmhg and the delta p was reading from positive to -69mmhg.The perfusionist plans to watch the patient and monitor cardiohelp in an attempt to prevent a change out.The customer has tried to disconnect the pressure sensor and reconnect without success.The customer indicated the patient is on support and stable at this time.In the morning ((b)(6) 2021 @ 1000) they decided to change out the hls set.The patient tolerated the change out well.The patient was covid positive, so the circuit was thrown away.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that initiation of vv (veno venous) support was at 1513 (b)(6) 2021.At 1830, part (arterial pressure) was jumping around from 33 to 220 mmhg and the delta p was reading from positive to -69mmhg.The perfusionist plans to watch the patient and monitor cardiohelp in an attempt to prevent a change out.The customer has tried to disconnect the pressure sensor and reconnect without success.The customer indicated the patient is on support and stable at this time.In the morning ((b)(6) 2021 @ 1000) they decided to change out the hls set.The patient tolerated the change out well.The patient was covid positive, so the circuit was thrown away.The affected product was not available for technical investigation of the manufacturer as it was discarded by the hospital.Thus the exact root cause of the reported event "part was jumping around & delta p was reading from positive to -69mmhg" could not be determined.The reported failure was investigated in a previous complaint and the root cause of the reported failure was determined to be a bent circuit board between the arterial pressure sensor and the flexible conductor.Additionaly the flexible conductor was not fully connected to the arterial pressure sensor.This was most probable caused by an assembly error or by external forces.The delta p reading is calculated as to be the pressure drop between the measured arterial pressure and the internal pressure.In this case the arterial pressure was not measured correctly, thus the delta p was influenced by the malfunction and therefore not displaying plausible values.Based on the above mentioned results the reported failure "part was jumping around & delta p was reading from positive to -69mmhg" could be confirmed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.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.

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12702985
• MDR Text Key: 278523128
• Report Number: 8010762-2021-00573
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

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: Health Professional
• Device Model Number: BEQ-HLS-7050
• Device Catalogue Number: 701052794
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1