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

Model Number BE-HQV 34611

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested for return and has not yet been received.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

It was reported the customer can easily remove he blue cap of the spike during priming of the tubing set.This could also disconnect from the line if you manipulate it during cardiopulmonary bypass, resulting in leakage.(b)(4).

Manufacturer Narrative

(b)(4).The product was investigated in the laboratory of the manufacturer.It was determined that the blue filter cap could be removed easily by hand.Maquet cardiopulmonary turkey was contacted in order to find out if the caps on their reserve samples for incoming inspection are sitting tight on the spike.It was confirmed, that they could not be removed easily as the customer complained.Based on this and the information available at this time the reported failure could be confirmed.The failure will be further investigated at the subsupplier for the affected component.A supplemental medwatch will be submitted when further information becomes available.This data will be handled through a designated maquet trending 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 action will be completed at this time.

Event Description

It was reported the customer can easily remove the blue cap of the spike during priming of the tubing set.This could also disconnect from the line if you manipulate it during cardiopulmonary bypass, resulting in leakage.(b)(4).

Manufacturer Narrative

On (b)(6) 2015 01:27 pm (gmt-5:00) added by (b)(6) ((b)(4)): the complaint data and investigation results were evaluated by the supplier (b)(4).A dhr review of the lot affected was performed with no abnormalities found.No scrap record for the related material was found.The supplier confirmed during their investigation of the complaint sample that the cap was very easily removable.No big measurement difference were found.The most probable cause of the failure was determined as material failure.As a corrective action, the supplier complaint has been opened to the sub supplier of the cap (ref.# (b)(4)).The sub supplier stated that the assembly process of the cap is outsourced.It was requested that the sub supplier implements qualification, training, process and in-process / final controls.Also the operators of (b)(4) have been informed about the complaint.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5084938
• MDR Text Key: 26305876
• Report Number: 8010762-2015-01048
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Model Number: BE-HQV 34611
• Device Catalogue Number: 70106.7740
• Device Lot Number: 92160017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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