MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number H 99100

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) requested the product back for manufacturer laboratory investigation but product has not yet been received.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the blood filter which is registered under 510(k): k001787.

Event Description

Customer opened set and noted that filter pall al3 was conversely mounted.(b)(4).

Manufacturer Narrative

The complaint has been investigated by maquet cardiopulmonary (b)(4).Thereby a device history record of the reported lot has been investigated and no abnormality was found.Based on the received picture the reported failure could be confirmed by maquet (b)(4).The most probable cause was determined as a failure caused by a operator mistake.As a corrective action a training has been performed with the explanation of the assembly of the filter.Furthermore the operators of maquet (b)(4) have been informed about the complaint.As soon as further information becomes available a supplemental medwatch will be submitted.

Event Description

(b)(4).

Manufacturer Narrative

Investigation has been performed in our laboratory.The filter has been inspected visually and it was found that the filter has been installed incorrectly.Additionally, the received complaint has been investigated by maquet cardiopulmonary (b)(4).Thereby a device history record of the reported lot has been investigated and no abnormality was found.Based on the received picture the reported failure could be confirmed by maquet (b)(4).The most probable cause was determined as a failure caused by a operator mistake.As a corrective action a training has been performed with the explanation of the assembly of the filter.Furthermore the operators of maquet (b)(4) have been informed about the complaint.Additionally, a review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found.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

(b)(4).

• Brand Name: HLM TUBING SET
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• 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: 5784306
• MDR Text Key: 49963785
• Report Number: 8010762-2016-00437
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K001787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: H 99100
• Device Catalogue Number: 70106.3568
• Device Lot Number: 92165707
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/12/2016; 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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