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

Model Number BEQ-HLS 7050 USA#HL

Device Problem Decrease in Pressure (1490)

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

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Device was requested but not yet received.

Event Description

According to the customer: customer called today to say that after they put a patient on cardiohelp, within 10 minutes of administering heparin per their protocol, they noticed a significant pressure drop (delta p) and an increase in arterial pressure (part).I got ptm, richard davila on the line to discuss the details of what was observed and per the discussion, richard thought there was probably some clot that was thrown from the patient which affected the disposable and there gave them the out of the ordinary readings.They switched out the disposable after this and everything was fine after that.No harm to the patient was reported.Internal reference: (b)(4).

Event Description

Internal reference: (b)(4).

Manufacturer Narrative

Maquet medical systems, usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: (b)(4).Importer- maquet medical systems usa 45 barbour pond drive wayne, nj 07470(b)(4).Contact person: (b)(4).The returned product was investigated in the laboratory of the manufacturer.An hls module advanced 7.0 has been returned.The sample was contaminated.No clots could be detected on the blood inlet outlet side.The luer lock of the venting membrane was missing the protective cap and was also contaminated.Module was cleaned with sodium hypochlorite.Created a water cycle with the cardio help.Oxygenator according to the ifu.The internal and arterial pressures showed no fluctuations.Protective cover of the pump removed.Bloody traces were found under the pump.The contacts and solder joints are covered with protective gel.The adhesive membranes of internal and venous pressure sensor are yellowish spots (as if they had been wet before).No further abnormalities could be detected.Thus the failure could not be confirmed.Further investigation steps are momentarily not possible to be executed due to work safety issues in the complaint laboratory.Maquet cardiopulmonary is currently in the mitigation of this issue.When further investigation steps can be executed again, these investigations will be performed and the complaint file will be updated accordingly.To determine the most probable root cause is not possible at this time due to work safety issues.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigate.Ion initiations will be completed at this time.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7847030
• MDR Text Key: 119826579
• Report Number: 8010762-2018-00253
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2020
• Device Model Number: BEQ-HLS 7050 USA#HL
• Device Catalogue Number: 701052794
• Device Lot Number: 70125206
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention