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 Backflow (1064)

Patient Problem Death (1802)

Event Date 07/16/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).Maquet cardiopulmonary (b)(4) requested the product for investigation in the laboratory of the manufacturer but not received yet.

Event Description

It was reported that cpr was being performed on a patient.The cardiohelp unit and disposable were brought to the room.Hls disposable was primed with no problems, but no forward flow occurred, once support was initiated.Reporter was not present and did not know what alarms or messages were occurring.Hls disposable was removed and a new one was primed and initiation of support occured with no issue.Patient did eventually expire.According to the principal cardiac assist territory manager: the death occurred during procedure.The set was primed but could not get any forward flow after priming.Set was exchanged.Second circuit was used.First circuit not placed on patient.After exchange there were no problems with the device.Condition of the patient before use was unstable.Internal reference: (b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Maquet cardiopulmonary (b)(4) requested the product for investigation in the laboratory of the manufacturer.The returned product was invesitigated in the laboratory of the manufacturer.The claimed oxygenator was disinfected, rinsed with water and treated with sodium hypochlorite cleaned.A visual examination, a functional test with the cardiohelp and a leak test after lv 201 were carried out.No clots were detected during the optical examination.The yellow cap from the vent connector has on delivery missing.It was made with the help of cardiohelp a water cycle and a function test performed.With no abnormalities.The forward flow worked perfectly.When leak test according to lv 201 was carried out, no leakage on the product detected.Thus the failure could not be confirmed.Most probable root cause could not be determined at this time because further investigation steps are momentarily not possible to be executed due to work safety issues in the complaint laboratory.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 7735186
• MDR Text Key: 115558971
• Report Number: 8010762-2018-00238
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2018,09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2019
• Device Model Number: BEQ-HLS 7050 USA#HL
• Device Catalogue Number: 701052794
• Device Lot Number: 70116216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2018
• Distributor Facility Aware Date: 09/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2018
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death