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

Model Number BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0

Device Problem Increase in Pressure (1491)

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

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in (b)(6).It was reported from the customer that the transmembrane pressure on the hls set (lot#70144130) jump from 19 mmhg to 65 mmhg during treatment.Perfusionist calls the intensivists to warn them that the tmp were increasing.Membrane was inspected, no signs of fibrin formation or clotting.Transmembrane pressures continue to go up.65 mmhg ->85 mmhg ->100 mmhg ->120 mmhg.Membrane is inspected again, still no signs of clotting on the post-membrane side.Customer checked the transmembrane pressures on the screen and the error message ¿pump disposable error¿ was noticed on the cardiohelp-i (s/n (b)(4)) and the flow is 0 lpm.Clamped the outflow line by hands and try to increase the rpm to get forward flow again, but they fall back to 0 rpm.With help from nursing, customer manage to get the used circuit onto the hand crank within 1 minutes (approximately) and begin cranking.Forward flow is established at 3.5 lpm and patient map and cerebral saturations were in the normal range.The backup perfusionist was on site, and called to bring backup ecmo circuit.The perfusionists preferred changing out the membrane because customer believed it would be the less risky option and would take the least amount of time.A second hls circuit (lot# 3000147588) was primed but unsuccessful.When the plasmalyte-a was dropped, customer were unable to prime by gravity or by increasing rpms.Both perfusionists took turns manipulating the circuit to try to get it primed but to no avail.When the rpms were increased, the cardiohelp-i (s/n (b)(4)) would make a loud rumbling sound, much louder and more vibrations than if the membrane were decoupled, which the perfusionists accounted for by detaching and reattaching the pump to the console as well as reducing the rpm to zero.Customer decide to switch the original circuit (currently being hand cranked) to the second cardiohelp-i.45 second circulatory arrest, and then flow was re-established, still with high tmp (around 175 mmhg at this point, but the pressures are not calibrated because it is now on the 2nd console) one perfusionist goes to get a third cardiohelp-i in the basement, and sets up a new circuit (3th hls set lot#70143125) and primes the set successful.Setting up the patient for circuit change out.Surgical resident and intensivist are scrubbed in, and the change out happens at the bedside in the icu.50 second arrest time, and full flow is established immediately.No indication of actual or potential for harm or death has been reported.The event will be investigated in further complaints: (b)(4), (b)(4), (b)(4).Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in canada.It was reported from the customer that the transmembrane pressure (tmp) on the hls set (lot#70144130) jump from 19 mmhg to 65 mmhg during treatment.Perfusionist calls the intensivists to warn them that the tmp were increasing.Membrane was inspected, no signs of fibrin formation or clotting.Tmp continue to go up.65 mmhg ->85 mmhg ->100 mmhg ->120 mmhg.Membrane is inspected again, still no signs of clotting on the post-membrane side.Customer checked the tmp on the screen and the error message ¿pump disposable error¿ was noticed on the cardiohelp-i (s/n (b)(6) ) and the flow is 0 lpm (liters per minutes).Clamped the outflow line by hands and try to increase the rpm (rounds per minutes) to get forward flow again, but they fall back to 0 rpm.With help from the nurse, customer manage to get the used circuit onto the hand crank within 1 minutes (approximately) and begin cranking.Forward flow is established at 3.5 lpm and cerebral saturations were in the normal range.The backup perfusionist was on site, and called to bring backup ecmo circuit.The perfusionists preferred changing out the membrane because customer believed it would be the less risky option and would take the least amount of time.A second hls circuit (lot# 3000147588) was primed but unsuccessful.When the plasmalyte-a was dropped, customer were unable to prime by gravity or by increasing rpms.Both perfusionists took turns manipulating the circuit to try to get it primed but to no avail.When the rpms were increased, the cardiohelp-i (s/n (b)(6) ) would make a loud rumbling sound, much louder and more vibrations than if the membrane were decoupled, which the perfusionists accounted for by detaching and reattaching the pump to the console as well as reducing the rpm to zero.Customer decide to switch the original circuit (currently being hand cranked) to the second cardiohelp-i (s/n (b)(6) ).45 second circulatory arrest, and then flow was reestablished, still with high tmp (around 175 mmhg at this point, but the pressures are not calibrated because it is now on the 2nd console) one perfusionist goes to get a third cardiohelp-i in the basement, and sets up a new circuit (3th hls set lot#70143125) and primes the set successfully.The procedure was finished with the third hls set.No harm to the patient was reported.Second hls set with lot# 3000147588 will be handled in complaint (b)(4).Cardiohelp-i with s/n (b)(6) will be in handled in complaint (b)(4).Cardiohelp-i with s/n (b)(6) will be in handled in complaint (b)(4).The affected hls set with lot number 70144130 was discarded by the hospital therefore a technical investigation could not be performed at the getinge laboratory.A review of the trend data for similar complaints was performed and no similar complaints were found.A device history record (dhr) review was performed on 2021-11-05 and there were no references found, which are indicating a nonconformance of the product in question.Following tests were performed on the hls module: - pressure test heat exchanger.- leak test water/gas side.- pressure test blood side.- final functional test.According to the final test results, all hls modules passed the tests as per specifications.Production related influences are unlikely.Based on the evaluated facts above, the reported failure "delta p increased" could not be confirmed.However the failure mode "delta p increased" can be linked to the following most possible root causes according to our risk management file (dms#(b)(4)).- deteriorating gas transfer.- blockage of oxygenator.- damage of gas fibers.- malfunction of oxygenator.- too low anticoagulation.- too low at level, effect of heparin is too limited.- protamine sulfate enters the hls set.- thrombozytopenia.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is 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.

Event Description

Complaint id: (b)(4).The event will be investigated in further complaints: (b)(4).

• 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: 11744723
• MDR Text Key: 250843768
• Report Number: 8010762-2021-00274
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Model Number: BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0
• Device Catalogue Number: 701052797
• Device Lot Number: 70144130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 60 KG