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

Model Number BEQ-HLS 7050-CA#HLS

Device Problem Break (1069)

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

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- (b)(4).Maquet (b)(4) requested the device for investigation in the laboratory of the manufacturer, but the product was no longer available.Already discarded by the hospital ,no laboratory investigation could be performed by the manufacturer.A review for similar complaints was performed and no similar complaints were found.The reported failure could be confirmed by the pictures provided by the customer.The probable root cause is unknown at this time.Also a dhr for the hls module is not possible, because the lot # is not available.The data is 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.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.

Event Description

According to the customer: customer has reported this event.Photos are available but the product was too covered with blood to preserve.Perfusionist began his shift and checked his circuit for leaks by tightening the stopcocks.When he attempted to verify the stopcock at the top on the arterial side, the luer part snapped as seen in photos.They had to replace the circuit with another one from the same lot number which worked fine.Patient was weaned off ecmo without issues 3 days later.The product is discarded by the hospital.No harm to the patient was reported.Internal reference: (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: 7789118
• MDR Text Key: 117569629
• Report Number: 8010762-2018-00244
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2020
• Device Model Number: BEQ-HLS 7050-CA#HLS
• Device Catalogue Number: 701064847
• Device Lot Number: 70124493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2018
• 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): Required Intervention