MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BO-HQV 7600

Device Problem Unintended Ejection (1234)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

According to the hospital: during the ecc procedure, the suction valve in the suction line(line 1 in the technical drawing) became leaking to the point of imposing its replacement.(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.(b)(4).The sample has not been returned to maquet for investigation in our laboratory.The device was disposed at the hospital.However, there is a picture related to the complaint.The investigation of the received picture showed that the leakage of the suction valve.Device history record of the complained lot was reviewed.There were no references found which are indicating a nonconformance of the product in question.Also, there is no nonconformity and no scar related to the claimed material.Sap trend search was performed (similar failure: 0114 leakage of the tube set components) which came to following results: 4 additional complaints were recorded which appears reported issues are the same since the last 12 months.Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0,21%, which is below 1%.Due to this information no systemic issue could be determined.There were no more detailed information and no detailed pictures about the complaint and the sample was not returned to us for investigation.The provided information with the complaint wasn¿t enough to determine the exact root cause the failure was confirmed.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

Ref.: #(b)(4), customer ref.:(b)(4).

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8078276
• MDR Text Key: 127552125
• Report Number: 8010762-2018-00303
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

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 Expiration Date: 08/05/2020
• Device Model Number: BO-HQV 7600
• Device Catalogue Number: 701050391
• Device Lot Number: 92241041
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention