MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: "the pediatric quad d that had a leak on the arterial side at the outlet.Slow leak.They had just put pt on.They grabbed another one and replaced.No patient effect." (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) received the product for investigation.A visual inspection was performed in the laboratory of the manufacturer.The blood inlet connector was sealed with adhesive tape upon arrival in the laboratory.The seal was removed and a crack on the inlet connector was detected.A tightness test according to lv 201 was performed and a leakage at the blood inlet connector, most probable caused by the crack was detected.Based on this the failure was confirmed.The manufacturer`s review of the quality control process indicated that a 100% functional inspection for leakage is conducted during manufacturing.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.The exact root-cause which led to the described failure could not be identified.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.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: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, 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: 6936116
• MDR Text Key: 90155380
• Report Number: 8010762-2017-00332
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: BEQ-HMOD30000-USA
• Device Catalogue Number: 701050330
• Device Lot Number: 70110255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Date Device Manufactured: 07/01/2016
• 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