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

Model Number 09684-S-J

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/23/2018

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: "when the customer attached the syringes to the three-way stopcocks, the syringes came off for several times.The customer added another three-way stopcock as the attached photo and continued the procedure." (b)(4).

Event Description

Ref.: #(b)(4), customer ref.: # (b)(6).

Manufacturer Narrative

(b)(4) (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: (b)(4).Contact person: (b)(4).The sample has not been returned to maquet for investigation in our laboratory.The device was disposed at the hospital.The lot number was requested at least three times from the ssu, but, they could not reach it.Therefore, device history record of the complained lot was not reviewed.A sap trend search was performed (material 70104.9356, failure code 1012 fitting problems) which came to following results: no additional complaint was 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: (b)(4).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 data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation initiations will be completed at this time.The failure could not be confirmed.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7620066
• MDR Text Key: 112003196
• Report Number: 8010762-2018-00214
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K053025
• 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: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 09684-S-J
• Device Catalogue Number: 701049356
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1