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

Model Number BEQ-HLS 7050 USA

Device Problem Pressure Problem (3012)

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

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: the p int pressure was labile from - 50 to -100, sometimes ----.The pressure cable was assessed with no obvious issue.Pressure cable was changed with no improvement in vacillating p int pressure.The cardiohelp unit was changed without improvement of the p int.The pressures it was showing were not clinically possible under the operating condition, as they were negative or -----.The disposable set was changed and the new set did not have any problems so issue was with pressure sensor of disposable.No harm to the patient was reported.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 ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person- (b)(6).The returned hls module advanced 7.0 has been investigated in the laboratory of the manufacturer on 2019-03-29.The sample was contaminated.The blood inlet side and blood outlet side were clotted.A yellow viscous fluid which was runs under the pump cover was detected.The liquid collected close to the p int sensor.Hls module was cleaned several times with sodium hypochlorite.The returned hls module was connected to the cardiohelp.The pint pressure was stable.The part was not displayed.Pump cover was removed.The yellow viscous fluid was also removed.The contacts of the pint sensor were corroded.No further abnormalities could be detected.Thus the failure could be confirmed.The most probable root cause could be that fluid entered and the sensor was corroded because the flexleiter which was build in the hls module was the old version (v03).Due to this a nc-15-02-173 was initiated in the past to avoid this reported failure (corroded sensors).The failure is already known to the manufacturer and has been thoroughly investigated under nc-15-02-173.In order to prevent reoccurrence of the reported issue the coating of the pins of the pressure sensor of the heimdall flexboard will be replaced with a coating that is resistant against saline solution.Electrolysis will then not occur in case of the unlikely event of saline solution entry into the hls module.It is the plan to verify and validate the new coating and to implement the new coating into production until (b)(6)2018.The implementation is already done but the affected hls module lot#70116159 (production date 2017-03-21) was produced before the implementation.

Event Description

Internal reference: (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
• MDR Report Key: 8426132
• MDR Text Key: 139183054
• Report Number: 8010762-2019-00068
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention